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Manufacturers
U-systems Inc
Manufacturer Address
U-systems Inc, 447 Indio Way, Sunnyvale CA 94085-4203
Source
USFDA
1 Event
Recall of Device Recall Soma v Automated Breast Ultrasound System
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One device in the database
Device Recall Soma v Automated Breast Ultrasound System
Model / Serial
Serial numbers: H1280099, H1180094, B1380105
Product Classification
Radiology Devices
Device Class
3
Implanted device?
No
Distribution
Distributed in California and Illinois.
Product Description
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. || Indicated as an adjunct to mammography for breast cancer screening.
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