510(k) K993861 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Feb 10, 2000 |
| Received | Nov 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993861
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2004 | Fujifilm Medical System USA, Inc. Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1.
Model: GP344 Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.