International Medical Devices Database

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

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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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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U-systems Inc

One device in the database

Device Recall Soma v Automated Breast Ultrasound System