IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
FDA premarket approval P970058/S022 · decided 2006-06-23
Approval details
- PMA number
- P970058
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
- Generic name
- Analyzer, medical image
- Applicant
- Hologic, Inc.
- Date received
- 2005-11-28
- Decision date
- 2006-06-23
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- APPROVAL OF NEW LABELING THAT WILL PRESENT THE SPECIFICITY OF CAD MARKS GENERATED BY R2 IMAGECHECKER COMPUTER AIDED DETECTION SYSTEM AS WELL AS ITS ABILITY TO MARK ACTIONABLE PRIORS. THE INDICATIONS FOR USE REMAIN AS PREVIOUSLY APPROVED: THE IMAGECHECKER M5000 IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON ROUTINE SCREENING MAMMOGRAMS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SYSTEM ASSISTS THE RADIOLOGIST
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