KODAK MAMMOGRAPHY CAD ENGINE
FDA premarket approval P030007/S003 · decided 2007-03-23
Approval details
- PMA number
- P030007
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- KODAK MAMMOGRAPHY CAD ENGINE
- Generic name
- Analyzer, medical image
- Applicant
- Carestream Health, Inc.
- Date received
- 2007-02-28
- Decision date
- 2007-03-23
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Rochester, NY
- 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.
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