Data / Medical devices / Screen, Intensifying, Radiographic
Screen, Intensifying, Radiographic (EAM): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Screen, Intensifying, Radiographic (product code EAM, Class 1, 21 CFR 892.1960). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 35 510(k) clearances under this code, the latest on December 22, 1997, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EAM
- Device class
- 1
- Regulation
- 892.1960
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| Japan | 2 |
| United States | 2 |
| South Korea | 1 |
| India | 1 |
Makers of Screen, Intensifying, Radiographic
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 |
|---|---|---|---|---|---|---|---|---|
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Manufacturer | 1 | February 26, 1987 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office | MINAMIASHIGARA-SHI Kanagawa, Japan | Manufacturer | 1 | February 26, 1987 | 0 | 0 | 0 | api.fda.gov |
| Carestream Dental LLC | Atlanta, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimedi.co.ltd | Wonju Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kiran Medical Systems A Div of Trivitron Healthcare Pvt. Ltd | Navi Mumbai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 22, 1997. 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.