Data / Medical devices / Radiology-Diagnostic Kit
Radiology-Diagnostic Kit (OIP): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Radiology-Diagnostic Kit (product code OIP, Class 2, 21 CFR 892.1680). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OIP
- Device class
- 2
- Regulation
- 892.1680
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Belgium | 1 |
| Germany | 1 |
| Mexico | 1 |
| Honduras | 1 |
Makers of Radiology-Diagnostic Kit
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 |
|---|---|---|---|---|---|---|---|---|
| Agfa N.V. | Mortsel Antwerpen, Belgium | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agfa-Gevaert Healthcare GMBH | PEISSENBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Hospital Supply Corp. | Indian Trail, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sheathing Technologies, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.