PMA P010038S008

Device: SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S008
Product code: MYN
Decision date: 2004-09-01
Classification: Analyzer, Medical Image
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR THE USE OF THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM WITH THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM AND IS INDICATED FOR: THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM 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 MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.

Current openFDA PMA Record#

Device: SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S008
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2004-09-01
Decision code: APPR
Date received: 2004-06-24
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM WITH THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM AND IS INDICATED FOR: THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM 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 MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.