PMA P010038S005

Device: ICAD SYSTEM
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S005
Product code: MYN
Decision date: 2003-10-31
Classification: Analyzer, Medical Image
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR 1) AN UPGRADED ALGORITHM FOR THE ICAD SYSTEM, 2) USE OF THE ICAD SYSTEM DIRECTLY WITH IMAGES OBTAINED ON THE FISCHER SENOSCAN FFDM SYSTEM, AND 3) THE NEW INCLUSION OF WOMEN WITH BREAST IMPLANTS IN THE TARGET POPULATION IN THE INDICATIONS FOR USE (IFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ICAD SYSTEM WITH THE FOLLOWING INDICATIONS FOR USE: THE ICAD IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM CASES FOR PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, 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: ICAD SYSTEM
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S005
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2003-10-31
Decision code: APPR
Date received: 2003-07-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1) AN UPGRADED ALGORITHM FOR THE ICAD SYSTEM, 2) USE OF THE ICAD SYSTEM DIRECTLY WITH IMAGES OBTAINED ON THE FISCHER SENOSCAN FFDM SYSTEM, AND 3) THE NEW INCLUSION OF WOMEN WITH BREAST IMPLANTS IN THE TARGET POPULATION IN THE INDICATIONS FOR USE (IFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ICAD SYSTEM WITH THE FOLLOWING INDICATIONS FOR USE: THE ICAD IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM CASES FOR PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, 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.