Data / Medical devices / Cabinet, X-Ray System
Cabinet, X-Ray System (MWP): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Cabinet, X-Ray System (product code MWP, Class 2, 21 CFR 892.1680). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on April 24, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MWP
- Device class
- 2
- Regulation
- 892.1680
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
| United Kingdom | 1 |
| Belgium | 1 |
Makers of Cabinet, X-Ray System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Kub Technologies, Inc. | Stratford, CT, United States | Manufacturer | 6 | September 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer, Remanufacturer | 5 | March 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cirdan Imaging Limited | Lisburn Antrim and Newtownabbey, United Kingdom | Manufacturer | 2 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Compai Healthcare (suzhou) Co.,ltd | Suzhou Jiangsu, China | Contract manufacturer, Manufacturer | 2 | April 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Compai Medtech (suzhou) Co.,ltd | Suzhou Jiangsu, China | Manufacturer | 2 | April 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Clarix Imaging Corp | Moorpark, CA, United States | Manufacturer | 1 | December 27, 2019 | 0 | 0 | 0 | api.fda.gov |
| Xeos Medical | Sint-Denijs-Westrem Oost-Vlaanderen, Belgium | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.