510(k) K080930 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
| Applicant | U-System, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Aug 7, 2008 |
| Received | Apr 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080930
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2013 | U-systems Inc Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound.
Indicated as an adjunct to mammography for breast cancer screening. Terminated |
PAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.