||June 24, 2013
||Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound.
Indicated as an adjunct to mammography for breast cancer screening.
||Serial numbers: H1280099, H1180094, B1380105
447 Indio Way
Sunnyvale, California 94085-4203
|For Additional Information Contact
408-570-1323 Ext. 308
|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].
||On 6/5/13, an "URGENT MEDICAL DEVICE CORRECTION" letter was distributed to all affected users, with a description of the problem and user corrective action steps. One consignee received an Urgent Notice to Customer - Medical Device Correction letter on 5/16/13. Contact the firm at 408-328-7925 for questions regarding this notice.
|Quantity in Commerce
||Distributed in California and Illinois.