Devices

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.
Manufacturer
U-systems Inc
1 Event
- Recall of Device Recall Soma v Automated Breast Ultrasound System

Manufacturer

U-systems Inc

Manufacturer Address
U-systems Inc, 447 Indio Way, Sunnyvale CA 94085-4203
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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