510(k) K023229 ยท IZH System, X-Ray, Mammographic
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
| Applicant | American Mammographics, Inc., Chattanooga TN, US |
| Decision | Substantially Equivalent, Dec 13, 2002 |
| Received | Sep 27, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023229
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.