510(k) K013897 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW
| Applicant | Bio-Scan S.A, Stamford CT, US |
| Decision | Substantially Equivalent, May 21, 2002 |
| Received | Nov 23, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K013897
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.