Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | KODAK MAMMOGRAPHY CAD ENGINE |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | CARESTREAM HEALTH,INC. 150 Verona Street ROCHESTER, NY 14608 |
PMA Number | P030007 |
Supplement Number | S003 |
Date Received | 02/28/2007 |
Decision Date | 03/23/2007 |
Withdrawal Date
|
11/13/2012 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |
|
|