510(k) K013218 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Dec 20, 2001 |
| Received | Sep 26, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K013218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Fujifilm Medical System USA, Inc. Fuji Flash IIP and CR-IR346CL Consoles Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.