PMA P010038S001

Device: ICAD
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S001
Product code: MYN
Decision date: 2003-02-24
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR USE OF THE 3.9.3.7 VERSION OF THE SOFTWARE. THE NEW SOFTWARE IS INTENDED TO IMPROVE THE OVERALL SENSITIVITY, IMPROVE THE BREAST SEGMENTATION PROCESS, REDUCE THE FALSE MARKER RATE AND IMPROVE THE OVERALL CONSISTENCY OF THE ALGORITHM. THE CLINICAL PERFORMANCE CLAIMS ARE NOT CHANGED.

Current openFDA PMA Record#

Device: ICAD
Applicant: Icad, Inc.
PMA number: P010038
Supplement: S001
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2003-02-24
Decision code: APPR
Date received: 2002-10-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR USE OF THE 3.9.3.7 VERSION OF THE SOFTWARE. THE NEW SOFTWARE IS INTENDED TO IMPROVE THE OVERALL SENSITIVITY, IMPROVE THE BREAST SEGMENTATION PROCESS, REDUCE THE FALSE MARKER RATE AND IMPROVE THE OVERALL CONSISTENCY OF THE ALGORITHM. THE CLINICAL PERFORMANCE CLAIMS ARE NOT CHANGED.