PMA P010038S012

Device: SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S012
Product code: MYN
Decision date: 2008-04-04
Classification: Analyzer, Medical Image
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR THE USE OF THE SECONDLOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY WITH FUJI MEDICAL SYSTEMS COMPUTED RADIOGRAPHY MAMMOGRAMS (CRM). THE DEVICE IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM FUJIFILM MEDICAL SYSTEMS COMPUTED RADIOGRAPHY SYSTEM (FUJI CRM) TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER AN INITIAL READING HAS BEEN COMPLETED.

Current openFDA PMA Record#

Device: SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S012
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2008-04-04
Decision code: APPR
Date received: 2006-07-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF THE SECONDLOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY WITH FUJI MEDICAL SYSTEMS COMPUTED RADIOGRAPHY MAMMOGRAMS (CRM). THE DEVICE IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM FUJIFILM MEDICAL SYSTEMS COMPUTED RADIOGRAPHY SYSTEM (FUJI CRM) TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER AN INITIAL READING HAS BEEN COMPLETED.