Data / Medical devices / Cassette, Radiographic Film
Cassette, Radiographic Film (IXA): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Cassette, Radiographic Film (product code IXA, Class 2, 21 CFR 892.1850). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 51 510(k) clearances under this code, the latest on September 10, 2008, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- IXA
- Device class
- 2
- Regulation
- 892.1850
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 3 |
| India | 1 |
Makers of Cassette, Radiographic Film
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 |
|---|---|---|---|---|---|---|---|---|
| Carestream Health, Inc | Rochester, NY, United States | Manufacturer | 2 | May 24, 2004 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Yuehua Medical Instrument Factory Co., Ltd. | Shantou Guangdong, China | Exporter to the US, Manufacturer | 1 | September 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 1 | February 19, 1980 | 0 | 0 | 0 | api.fda.gov |
| Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd | Navi Mumbai Maharashtra, India | Contract manufacturer, Manufacturer | 1 | May 7, 1990 | 0 | 0 | 0 | api.fda.gov |
| Ashland | Columbus, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashland Specialty Ingredients, G.P. | Bridgewater, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashland Specialty Ingredients, G.P. | Fiskeville, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 10, 2008. 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.