PMA P100005S004

Device
M-VU ALGORITHM ENGINE
Applicant
Icad, Inc.
PMA number
P100005
Supplement
S004
Product code
MYN
Decision date
2014-06-06
Generic name
Analyzer, medical image
Approval order statement
APPROVAL FOR M-VU® ALGORITHM ENGINE VERSION 3.1.0.0 WITH SHORTER EXECUTION TIME.

Current openFDA PMA Record#

Device
M-VU ALGORITHM ENGINE
Applicant
Icad, Inc.
PMA number
P100005
Supplement
S004
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2014-06-06
Decision code
APPR
Date received
2014-05-19
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR M-VU® ALGORITHM ENGINE VERSION 3.1.0.0 WITH SHORTER EXECUTION TIME.