IMAGE CHECKER (CAD) SYSTEM, M1000
FDA premarket approval P970058/S010 · decided 2001-05-29
Approval details
- PMA number
- P970058
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMAGE CHECKER (CAD) SYSTEM, M1000
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2001-04-19
- Decision date
- 2001-05-29
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL FOR THE EXPANSION OF THE INDICATIONS FOR USE TO COVER DIAGNOSTIC AS WELL AS SCREENING MAMMOGRAMS. THE NEW INDICATIONS FOR USE IS: THE IMAGECHECKER M1000 IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING AND DIAGNOSTIC MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGR
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