PMA P970058S026

Device
IMAGE CHECKER CAD
Applicant
Hologic, Inc.
PMA number
P970058
Supplement
S026
Product code
MYN
Decision date
2014-02-10
Generic name
Analyzer, medical image
Approval order statement
APPROVAL OF IMAGECHECKER CAD 10.0 FOR USE WITH C-VIEW IMAGES SYNTHESIZED BY THE HOLOGIC SELENIA DIMENSIONS SYSTEM.

Current openFDA PMA Record#

Device
IMAGE CHECKER CAD
Applicant
Hologic, Inc.
PMA number
P970058
Supplement
S026
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2014-02-10
Decision code
APPR
Date received
2013-10-17
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL OF IMAGECHECKER CAD 10.0 FOR USE WITH C-VIEW IMAGES SYNTHESIZED BY THE HOLOGIC SELENIA DIMENSIONS SYSTEM.