KODAK MAMMOGRAPHY CAD ENGINE
FDA premarket approval P030007 · decided 2004-11-23
Approval details
- PMA number
- P030007
- Trade name
- KODAK MAMMOGRAPHY CAD ENGINE
- Generic name
- Analyzer, medical image
- Applicant
- Carestream Health, Inc.
- Date received
- 2003-03-31
- Decision date
- 2004-11-23
- Days to decision
- 603 days
- Decision code
- APWD
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE KODAK MAMMOGRAPHY CAD ENGINE. THE KODAK MAMMOGRAPHY CAD ENGINE IS A SOFTWARE PACKAGE 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 SOFTWARE ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
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510(k) clearances by this applicant
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