IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)
FDA premarket approval P970058/S018 · decided 2003-11-26
Approval details
- PMA number
- P970058
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2003-10-22
- Decision date
- 2003-11-26
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR THE USE OF THE IMAGECHECKER SYSTEM WITH THE FISCHER IMAGING'S SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER D (DIGITAL MAMMOGRAPHY ONLY), IMAGECHECKER DM (DIGITAL AND ANALOG MAMMOGRAPHY), AND IMAGECHECKER OEM-D (DIGITAL MAMMOGRAPHY ONLY, SOLD BY FFDM VENDOR). THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.1. THE INDICATIONS FOR USE ARE: THE IMAGECHECKER D/DM.OEM-D IS A COMPUTER SYSTEM INTEND
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