510(k) K052355 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
| Applicant | U-Systems, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Sep 14, 2005 |
| Received | Aug 29, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052355
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.