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Panels › Radiology › Product code SHE · Class 2

Radiological Software System For Delivery Date Prediction

Regulation 892.8200

1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in SHE

Company510(k)sRecalls
Ultrasound AI10
Decided510(k)Device and applicantCode
Feb 11, 2026DEN250007Delivery Date AI
Ultrasound AI
SHE

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