SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY
FDA premarket approval P010034/S003 · decided 2003-08-11
Approval details
- PMA number
- P010034
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2003-02-27
- Decision date
- 2003-08-11
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE SECOND LOOK DIGITAL CAD SYSTEM FOR GEMS SENOGRAPHIE 2000D FULL FIELD DIGITAL MAMMOGRAPHY. THE CHANGES INCLUDE SOFTWARE UPGRADE TO ACCOMMODATE DIGITAL IMAGE PROCESSING AND AN ADDITION OF RACK MOUNTABLE HARDWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY AND IS INDICATED FOR IDENTIFICATION AND MARKING REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM GENERAL ELECTRIC MEDICAL SYSTEMS SENOGRAPHIE 2000D
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