Product code PAA ยท Class 3
Automated Breast Ultrasound
0510(k)s in 12 months (0 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PAA
| Company | 510(k)s | Recalls |
|---|---|---|
| U-systems Inc | 0 | 1 |
| 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 | K080930 |
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