PMA P100005S001

Device
M-VU ALGOIRITHM ENGINE
Applicant
Icad, Inc.
PMA number
P100005
Supplement
S001
Product code
MYN
Decision date
2012-10-01
Generic name
Analyzer, medical image
Approval order statement
APPROVAL FOR ALGORITHM UPDATES AND THE EXPANSION TO MULTIPLE MAMMOGRAPHY SYSTEMS.

Current openFDA PMA Record#

Device
M-VU ALGOIRITHM ENGINE
Applicant
Icad, Inc.
PMA number
P100005
Supplement
S001
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2012-10-01
Decision code
APPR
Date received
2012-05-21
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR ALGORITHM UPDATES AND THE EXPANSION TO MULTIPLE MAMMOGRAPHY SYSTEMS.