PMA P030007S003

Device: KODAK MAMMOGRAPHY CAD ENGINE
Applicant: Carestream Health, Inc.
PMA number: P030007
Supplement: S003
Product code: MYN
Decision date: 2007-03-23
Classification: Radiology
Generic name: Analyzer, medical image
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT EASTMAN KODAK COMPANY, ROCHESTER, NEW YORK. THIS IS ASOFTWARE MANUFACTURING LOCATION CHANGE THAT CONSISTS OF A SERVER MOVE FROM SAN JOSE, CALIFORNIA TO ROCHESTER, NEW YORK.

Current openFDA PMA Record#

Device: KODAK MAMMOGRAPHY CAD ENGINE
Applicant: Carestream Health, Inc.
PMA number: P030007
Supplement: S003
Product code: MYN
Generic name: Analyzer, medical image
Decision date: 2007-03-23
Decision code: APPR
Date received: 2007-02-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT EASTMAN KODAK COMPANY, ROCHESTER, NEW YORK. THIS IS ASOFTWARE MANUFACTURING LOCATION CHANGE THAT CONSISTS OF A SERVER MOVE FROM SAN JOSE, CALIFORNIA TO ROCHESTER, NEW YORK.