IMAGE CHECKER M1000
FDA premarket approval P970058/S005 · decided 1999-10-05
Approval details
- PMA number
- P970058
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGE CHECKER M1000
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 1999-09-08
- Decision date
- 1999-10-05
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for the addition of the Canon Model 300 digitizer as an optional digitizer for the ImageChecker M1000.
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