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Automated Breast Ultrasound
FDA product code PAA · Class 3 · Unknown
17
Registered devices
8
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — CARDINAL HEALTH 200, LLCInvenia — GE Medical Systems, Ultrasound & Primary Care Diagnostics LLCInvenia — GE Medical Systems, Ultrasound & Primary Care Diagnostics LLCInvenia — GE Medical Systems, Ultrasound & Primary Care Diagnostics LLCInvenia — GE Medical Systems, Ultrasound & Primary Care Diagnostics LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCInvenia — GE Medical Systems, Ultrasound & Primary Care Diagnostics LLCInvenia — GE Medical Systems, Ultrasound & Primary Care Diagnostics LLCSoftVue — Delphinus Medical Technologies, IncInvenia — GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLCCARDINAL HEALTH — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-05-16 | U-systems Inc | Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum |
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