Classification conclusion
Classification, duty and FDA/CDRH compliance for a non-medical cabinet X-ray machine used to inspect PCB and PCBA solder joints.
| Field | Conclusion |
|---|---|
| Proposed HTS code | 9022190000 — Non-medical X-ray apparatus, for other uses |
| Jurisdiction | United States |
| Tariff edition | HTSUS 2026 |
| Rules applied | GIR/GRI 1 and 6 |
| Confidence | High when the entered merchandise matches the stated facts |
| Condition | A complete, non-medical cabinet X-ray system used for nondestructive inspection of solder joints and hidden defects in PCB/PCBA assemblies. |
What is the U.S. HTS code for a PCB X-ray inspection machine?
For a complete non-medical X-ray inspection system used to examine solder joints and hidden defects in printed circuit boards or printed circuit board assemblies, the appropriate U.S. classification is generally HTSUS 9022.19.0000.
| Issue | U.S. import conclusion |
|---|---|
| Product | Cabinet-style X-ray inspection machine for PCB/PCBA quality control |
| HTSUS number | 9022.19.0000 — Apparatus based on the use of X-rays, for other uses |
| General duty rate | Free under the 2026 HTSUS |
| General import license | Not ordinarily required solely because the machine uses X-rays |
| FDA/CDRH status | Radiation-emitting electronic product; 21 C.F.R. requirements apply |
| FDA import declaration | Form FDA 2877 and product/manufacturer compliance data are normally required |
| Medical-device clearance | Not required solely for non-medical PCB inspection use |
| State requirements | Radiation-machine registration and user licensing may apply after import |
| Confidence | High when the imported article is a complete non-medical X-ray inspection machine |
This conclusion does not automatically cover an optical AOI machine, an electrical ICT/FCT tester, a stand-alone X-ray tube or detector, a medical imaging device, or an industrial computed-tomography system whose objective characteristics materially differ from a conventional cabinet PCB inspection machine.
Why HTSUS 9022.19.0000 applies
GRI 1 requires classification according to the terms of the headings and relevant Section and Chapter Notes. Heading 9022 expressly covers apparatus based on the use of X-rays, including radiography apparatus and X-ray generators.
The imported machine creates X-rays, passes them through a circuit board and records the resulting image with a detector. Image-processing software may locate voids, insufficient solder, bridges, cracks or misaligned components, but the machine's governing operating principle remains the use of X-rays. Heading 9022 is therefore more specific than residual measuring or checking headings.
GRI 6 places non-medical X-ray apparatus in subheading 9022.19. The U.S. statistical line is 9022.19.0000, “For other uses.” The word “other” distinguishes the equipment from medical, surgical, dental and veterinary X-ray apparatus; it does not mean that the machine lacks a defined industrial use.
CBP rulings supporting the classification
CBP has repeatedly classified complete non-medical X-ray instruments in 9022.19.0000:
- NY N309082 classified a complete X-ray fluorescence analyzer used for industrial analysis in 9022.19.0000 and stated that the general duty rate was free.
- NY 874114 classified an X-ray instrument used to analyze semiconductor wafers in 9022.19.0000.
- NY E81197 classified non-medical X-ray fluorescence apparatus in 9022.19.0000 and also identified FDA Form 2877 as an import-compliance issue.
- CROSS search results for 9022.19.0000 provide additional decisions involving industrial X-ray imaging and analysis systems.
No published ruling located for this article describes every feature of a modern automated PCB X-ray machine. The rulings are persuasive because they apply the same legal distinction: a complete apparatus whose operation is based on X-rays and whose use is non-medical belongs in 9022.19.0000. A ruling binds only the requesting party and the merchandise described; an importer seeking certainty for a materially different automated CT or in-line system should consider a prospective CBP ruling under 19 C.F.R. Part 177.
When a different classification analysis is required
| Merchandise as entered | Classification issue |
|---|---|
| AOI system using cameras and visible light only | Heading 9022 does not apply; analyze the optical/checking function |
| Stand-alone X-ray tube | Review 9022.30.0000 |
| Detector, high-voltage generator, control panel or dedicated part | Review the parts and accessories provisions of heading 9022 |
| Medical or veterinary imaging system | Review 9022.12 through 9022.14 and FDA medical-device requirements |
| Multiple independent machines imported as a line | Classify each machine or apply GRI 2(a)/3 only when legally justified |
| Industrial CT system with a broader function | Confirm the complete operating principle, configuration and intended use; do not rely only on the label “PCB inspection” |
Duty rate and origin-dependent additional tariffs
The 2026 HTSUS general rate for 9022.19.0000 is Free. Importers should verify the live line in the USITC Harmonized Tariff Schedule on the date of entry.
“Free” is the Column 1 general rate, not a promise that every origin enters without additional duty. Products of China may require one or more Chapter 99 numbers under then-current Section 301 or other tariff actions. The applicable Chapter 99 treatment depends on country of origin, product scope, exclusions and entry date. It must be checked against the live HTSUS and USTR/CBP instructions rather than copied from an old ruling or entry.
Country of shipment is not necessarily country of origin. Where the X-ray source, detector, cabinet, motion platform and control system are produced in different countries, the importer should retain a manufacturing flow and bill of materials sufficient to support the substantial-transformation analysis.
FDA requirements for a cabinet X-ray system
FDA identifies circuit-board inspection as an industrial quality-control use of a cabinet X-ray system. A non-medical PCB inspection machine is still a radiation-emitting electronic product regulated by FDA's Center for Devices and Radiological Health.
The principal performance standard is 21 C.F.R. § 1020.40. Among other requirements, it addresses cabinet construction, interlocks, warning indicators, labels and radiation-emission limits. The standard limits radiation emitted from the external surface of a cabinet X-ray system to the regulatory level measured at the prescribed distance.
FDA's Cabinet X-Ray Systems guidance expressly lists circuit-board inspection among common industrial applications. The manufacturer must satisfy applicable provisions of 21 C.F.R. Parts 1000–1005, 1010 and 1020, including product reporting and certification requirements.
What the importer should have before entry
For an imported radiation-emitting electronic product, the entry record normally includes Form FDA 2877, “Declaration for Imported Electronic Products Subject to Radiation Control Standards.” FDA explains the process in Importing Radiation-Emitting Electronic Products.
The importer should obtain from the manufacturer:
1. The FDA establishment/manufacturer identification information. 2. The product report accession number when required for the model. 3. A photograph and text of the U.S. certification label. 4. Test data supporting compliance with 21 C.F.R. § 1020.40. 5. The user manual, interlock description and radiation-safety instructions. 6. Model, serial number, X-ray-tube voltage/current and cabinet configuration.
FDA may detain or refuse a product that lacks the required certification label or cannot be matched to the manufacturer's radiation product reporting. A CE mark or foreign radiation-safety report does not replace U.S. federal certification.
Is a 510(k) required?
Not merely because the machine generates X-rays. A cabinet system designed and labeled exclusively for PCB/PCBA inspection is not a medical device solely by reason of its radiation source. It remains subject to electronic-product radiation control.
The conclusion changes if the product is promoted or intended for diagnosis, treatment, medical imaging, veterinary use or examination of people. Intended use, labeling, software claims and sales materials must all remain consistent with industrial quality control.
State radiation-control and workplace obligations
Federal import compliance does not replace state rules governing possession and operation of radiation-producing machines. Depending on the installation state, the owner may need to register the machine with the state radiation-control program, designate a radiation-safety officer, maintain surveys and training, and notify the regulator before operation.
The Conference of Radiation Control Program Directors provides links to state programs, but the importer should confirm requirements directly with the state agency where the machine will be installed. OSHA requirements, lockout/tagout procedures and employer safety obligations may also apply.
Other U.S. import controls to review
- Country-of-origin marking: 19 U.S.C. § 1304 and 19 C.F.R. Part 134 generally require marking the article or its container with the correct origin.
- FCC: Computers, digital controllers and wireless modules incorporated into the machine may be subject to Part 15 equipment-authorization requirements even though the X-ray function is regulated by FDA.
- UFLPA: Importers should retain supply-chain evidence for high-risk inputs and production locations.
- Export controls: High-resolution industrial CT, semiconductor inspection technology, software and certain end uses may require a separate EAR/OFAC analysis; tariff classification does not determine export-control classification.
- Used equipment: Used machines are not categorically prohibited, but condition, value, FDA certification, modifications and state registration must be verified carefully.
Entry description and supporting documents
Suggested commercial description: “Non-medical cabinet X-ray inspection system for nondestructive inspection of solder joints on printed circuit board assemblies, model ..., ... kV X-ray tube, detector and shielded cabinet, new.”
The customs file should include:
1. Manufacturer datasheet explaining the X-ray operating principle and PCB/PCBA inspection use. 2. Photographs of the complete imported configuration and model/serial label. 3. X-ray tube voltage/current, detector type and cabinet shielding specifications. 4. FDA Form 2877 data, accession number and certification-label evidence. 5. Bill of materials and manufacturing process supporting country of origin. 6. Invoice and packing list consistent with the actual complete system.
Primary authorities
- U.S. International Trade Commission — 2026 Harmonized Tariff Schedule of the United States
- U.S. Customs and Border Protection — NY N309082, industrial X-ray analyzer under 9022.19.0000
- U.S. Customs and Border Protection — NY 874114, semiconductor-wafer X-ray instrument
- U.S. Food and Drug Administration — Cabinet X-Ray Systems
- Electronic Code of Federal Regulations — 21 C.F.R. § 1020.40
- U.S. Food and Drug Administration — Importing Radiation-Emitting Electronic Products
Customs conclusion
HTSUS 9022.19.0000 is well supported when the article entered is a complete, non-medical PCB X-ray inspection machine. The three facts most likely to change the analysis are whether the machine actually generates X-rays, whether the shipment is a complete machine or a component, and whether the intended use is industrial or medical.
The base duty rate is only one part of compliance. A workable entry plan must also address FDA radiation-product reporting and certification, Form FDA 2877, origin-specific Chapter 99 duties, and the radiation-machine rules of the state where the equipment will operate.
2026 U.S. customs and import-law review
Legal review date: September 5, 2026. The USITC online HTSUS identified 2026 Revision 18 on this review date. Rates and Chapter 99 measures can change during the year, so the legally operative schedule is the edition in effect on the entry date.
1. Quick legal conclusion
The proposed reporting number is 9022190000 for Non-medical X-ray apparatus, for other uses, but only for merchandise that matches this defined scope: A complete, non-medical cabinet X-ray system used for nondestructive inspection of solder joints and hidden defects in PCB/PCBA assemblies. This is a fact-dependent classification opinion, not a CBP ruling and not a determination of admissibility, origin or AD/CVD scope.
2. Facts that must be verified before entry
- X-ray source and detector configuration
- PCB/PCBA solder-joint inspection use
- 2D cabinet system versus industrial CT/radiography
Also obtain the complete bill of materials, technical drawings, model numbers, operating manual, condition and configuration as imported, transaction chain, manufacturer/producer, country of origin of material inputs and intended U.S. use. A material difference requires a new analysis.
3. HTSUS analysis and controlling authority
- GRI 1 places apparatus whose operation is based on X-rays in heading 9022.
- GRI 6 selects the national non-medical or PCB-specific X-ray subheading in each jurisdiction.
The analysis must begin with GRI 1, the heading text and binding Section/Chapter Notes, then proceed to GRI 2–5 only if legally necessary and to GRI 6 for subheadings. U.S. Additional Rules of Interpretation and Additional U.S. Notes are controlling where applicable. WCO Explanatory Notes are persuasive interpretive material but are not U.S. statutory text. A CROSS ruling is binding only for the requester and merchandise covered by its facts; materially similar rulings may be persuasive. CIT and Federal Circuit decisions control within their jurisdiction.
Goods outside this opinion include:
- Optical AOI, electrical testers, medical X-ray equipment, stand-alone components and industrial CT systems require separate analysis.
For recurring or high-value entries, request a prospective binding ruling from CBP under 19 CFR Part 177 and disclose all material facts. A ruling request is not a substitute for checking post-ruling HTSUS amendments or trade remedies.
4. Duty, fee and tax matrix
| Charge | Legal treatment for this article |
|---|---|
| HTSUS Column 1 General duty | Apply the rate printed beside 9022190000 in the HTSUS edition effective on the entry date. Any rate stated elsewhere in the article remains provisional until that check is completed. |
| Merchandise Processing Fee (MPF) | Formal entries generally incur 0.3464% of entered value, excluding duty, freight and insurance, subject for FY 2026 to the CBP minimum $33.58 and maximum $651.50; an applicable preference program can alter MPF treatment. |
| Harbor Maintenance Fee (HMF) | 0.125% of value when commercial cargo is unloaded from a vessel at a covered U.S. port; it ordinarily does not apply to air freight. See 26 U.S.C. 4461–4462 and 19 CFR 24.24. |
| Section 301 / other Chapter 99 duty | Determine from the exact 8-digit HTSUS provision, country of origin, effective date and any valid exclusion. Report the required Chapter 99 number; do not assume the base HTS rate is the total landed duty. |
| Section 232 | Check current Chapter 99 notes, product/derivative coverage, origin and any required steel/aluminum/copper content, melt-and-pour or smelt-and-cast data. It does not apply merely because the article contains some metal. |
| AD duty | Not determinable from an HTS number. The written scope of an AD order is dispositive; HTS references are for convenience. Review product, producer/exporter, origin and circumvention findings. Cash-deposit and final assessment rates can differ. |
| CVD duty | The same written-scope rule applies. Confirm the case-specific company or all-others cash-deposit rate and liquidation instructions in Commerce ACCESS and ACE. |
| Safeguard / quota | Check current Chapter 99, quota and safeguard measures as of entry. Product scope, origin, quantity and quota period control. |
| Federal excise tax | No product-specific federal excise tax is identified from the stated facts; confirm the intended use and the current Internal Revenue Code before entry. |
| State sales/use and other state taxes | These are not CBP customs duties. They depend on destination, importer nexus, later sale/use and state/local law and require a separate domestic-tax review. |
This table does not calculate landed cost. The importer must also determine customs value under 19 U.S.C. 1401a, including assists, packing, royalties/license fees, proceeds and related-party acceptability. A “first sale” claim requires a bona fide sale for export to the United States, arm's-length evidence and a complete transaction trail.
5. AD/CVD and evasion review
Do not infer trade-remedy status from the HTS number alone. Screen the country of origin, producer and written scope of every active AD/CVD order, and test any applicable Chapter 99 provision as of the entry date.
The written scope description is dispositive; an HTSUS number in an order is only a convenience reference. If coverage is uncertain, obtain a Commerce scope ruling under 19 CFR 351.225 before relying on a non-covered position. Minor processing or assembly in a third country can trigger a circumvention analysis. False origin, undervaluation or evasion can lead to EAPA investigation under 19 U.S.C. 1517 and civil penalties under 19 U.S.C. 1592.
6. Partner Government Agency and product compliance
An X-ray inspection system is a radiation-emitting electronic product. Before shipment, determine the FDA/CDRH reporting, accession-number, labeling and import declaration requirements under the Federal Food, Drug, and Cosmetic Act and 21 CFR Parts 1000–1050; state radiation-control registration or licensing may also apply after importation.
PGA admissibility is independent of tariff classification. Transmit all required agency data and documents through ACE; a CBP release does not cure a violation of an FDA, CPSC, EPA, FCC, DOT, USDA or other agency rule.
7. Origin, marking and UFLPA
Determine nonpreferential origin under the substantial-transformation test and any product-specific rule; do not rely only on the shipping country, invoice origin or location of final packing. Mark the article and, when required, its container under 19 U.S.C. 1304 and 19 CFR Part 134, unless a documented exception applies. Section 301, AD/CVD, government procurement and a preference program may use distinct origin rules.
Under 19 U.S.C. 1307 and the UFLPA, goods mined, produced or manufactured wholly or in part in Xinjiang, or by an entity on the UFLPA Entity List, are subject to a rebuttable presumption of exclusion. Maintain supplier identity, production, payment, logistics and input-tracing evidence; a generic supplier declaration is not enough for a high-risk supply chain.
8. Minimum entry file
- CBP entry/cargo release data and Form 7501 record, customs bond, commercial invoice, packing list and bill of lading/air waybill.
- Purchase orders, payment records, Incoterms, assists/royalties analysis and related-party or first-sale valuation support.
- Product specifications, drawings, photographs, manuals, composition/BOM, model cross-reference and condition as imported.
- Signed classification memorandum applying the GRIs, legal notes, current HTSUS text and relevant rulings, plus rejected alternatives.
- Origin and marking analysis; producer/supplier affidavits and traceability records; Chapter 99 and exclusion support.
- AD/CVD scope search, producer/exporter case numbers and cash-deposit instructions, even when the conclusion is “not covered.”
- All PGA registrations, certificates, laboratory reports, licenses, notices and ACE data required for this product.
Keep entry and supporting records for the statutory period, generally five years, under 19 U.S.C. 1508 and 19 CFR Part 163.
9. Principal legal risks
- Declaring a 10-digit number from the trade name without proving the imported condition and legally relevant characteristics.
- Omitting a Chapter 99 number or calculating only the Column 1 rate.
- Treating an AD/CVD HTS cross-reference as dispositive instead of reading the written scope.
- Using shipping country as origin without a substantial-transformation and marking analysis.
- Filing before PGA admissibility, certificates, laboratory evidence or supply-chain traceability are complete.
An incorrect entry can produce redelivery, exclusion/seizure, duty reassessment, interest, loss of liquidation defenses and penalties. If past entries contain a material error, promptly evaluate a post-summary correction, protest, prior disclosure under 19 CFR 162.74 or other corrective procedure with U.S. customs counsel; the correct route depends on entry and liquidation status.
10. Pre-entry action checklist
1. Lock the specifications and imported configuration for the exact SKU. 2. Re-run classification against the current HTSUS and record GRI/Note reasoning. 3. Determine customs value, nonpreferential origin and marking. 4. Screen Chapter 99, Section 301/232, quota/safeguard and every potentially relevant AD/CVD scope. 5. Complete the product-specific PGA review and obtain supporting certificates before shipment. 6. Calculate landed duties and fees, then have the importer and licensed customs broker validate ACE reporting. 7. For unresolved or commercially material classification issues, obtain a CBP Part 177 ruling before importation.
Official legal sources
- United States International Trade Commission; HTSUS 2026: Harmonized Tariff Schedule of the United States
- U.S. Customs and Border Protection; NY N309082: Industrial X-ray analyzer classified in 9022.19.0000
- U.S. Food and Drug Administration; 21 CFR 1020.40: Cabinet X-ray systems and radiation-emitting product requirements
- USITC — Current Harmonized Tariff Schedule of the United States
- CBP — User fee table: MPF rate and FY 2026 minimum/maximum
- CBP — Harbor Maintenance Fee
- CBP — ACE: filing customs and Partner Government Agency data
- USTR — Section 301 tariff actions and exclusion search
- BIS — Section 232 steel and aluminum measures
- Commerce — AD/CVD FAQs, scope and circumvention rules
- Commerce — ACCESS AD/CVD proceeding search
- CBP — UFLPA rebuttable presumption
- CPSC — Certificates and mandatory eFiling guidance
- FDA — Importing food products into the United States
- EPA — TSCA requirements for importing chemicals
- PHMSA — Lithium battery transportation requirements
- FCC — Equipment authorization
- eCFR — 19 CFR Part 177: administrative rulings
- eCFR — 19 CFR Part 134: country-of-origin marking
- eCFR — 19 CFR Part 163: recordkeeping
> Legal notice: This article provides general U.S. customs and trade-compliance information based on the stated facts as of September 5, 2026. It is not a CBP, Commerce or PGA ruling and is not legal advice for a specific transaction. Current HTSUS/Chapter 99 text, agency requirements and case-specific AD/CVD instructions must be rechecked at entry.
Editorial note
Prepared by the Global HS Code Checker Editorial Team for customs-classification, tariff and import-policy research. The correct code and applicable measures may change with the merchandise's actual characteristics, jurisdiction, entry date and supporting record. Verify the current tariff, governing measures and competent customs authority before filing an entry. A reviewer is identified only after a named expert has completed the review.