510(k) K032640 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | U-Systems, Inc., Los Altos, CA, US |
| Decision | Substantially Equivalent, Sep 11, 2003 |
| Received | Aug 27, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032640
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.