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Devices
Mammography Xray system.
Model / Serial
Serial Numbers: 9800-0103-001, 9800-0104-001, 0900-0104-002, 9800-0104-003, 9800-0203-001, 9800-0204-001, 9800-0204-002, 9800-0204-004, 9800-0204-005, 9800-0303-003, 9800-0402-003, 9800 0403-001, 9800-0502-001, 9800-0602-001R, 9800-0603-001, 9800-0603-002, 9800-0901-001R, 9800-0903-001, 9800-1001-001, 9800-1003-003, 9800-1003-004, 9800-1102-003, 9800-1102-007, 9800-1103-001, 9800-1103-002, 9800-1103-003, 9800-1103-004, 9800-1103-005, 9800-1103-006, 9800-1103-007, 9800-1103-008, 9800-1103-009, 9800-1103-011, 9800-1103-012, 9800-1202-003, 9800-1203-001, 9800-1203-002.
Product Classification
Radiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution.
Product Description
SenoScan True View Digital Mammography System
Manufacturer
Fischer Imaging Corporation
1 Event
Recall of Mammography Xray system.
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Manufacturer
Fischer Imaging Corporation
Manufacturer Address
Fischer Imaging Corporation, 12300 Grant St, Denver CO 80241-3120
Source
USFDA
Language
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