FDA-Device2013-07-03Class II
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
U-systems Inc
Hazard
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 ABUS [a 510(k) product].
Sold states
Distributed in California and Illinois.
Affected count
3 units
Manufactured in
447 Indio Way, Sunnyvale, CA, United States
Products
Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1587-2013Don't want to check this manually?
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