IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)
FDA premarket approval P970058/S019 · decided 2004-04-07
Approval details
- PMA number
- P970058
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2004-03-01
- Decision date
- 2004-04-07
- Days to decision
- 37 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 HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHIC SYSTEM AND EQUIVALENT PRIVATE LABEL DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES IMAGECHECKER M5000D (DIGITAL MAMMOGRAPHY ONLY) AND IMAGECHECKER M5000DM (DIGITAL AND ANALOG MAMMOGRAPHY). THE MODIFIED DEVICE WOULD BE SUPPORTED BY SOFTWARE VERSION 5.2. THE INDICATIONS FOR USE ARE: THE IMAGECHECKER M5000D/DM IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS O
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