M1000 IMAGECHECKER
FDA premarket approval P970058 · decided 1998-06-26
Approval details
- PMA number
- P970058
- Trade name
- M1000 IMAGECHECKER
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 1997-12-16
- Decision date
- 1998-06-26
- Days to decision
- 192 days
- Decision code
- APRL
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- The Image Checker M1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them tot he attention of the radiologist after the initial readin ghas been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.
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