ICAD SYSTEM
FDA premarket approval P010038/S007 · decided 2004-05-19
Approval details
- PMA number
- P010038
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ICAD SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2004-04-28
- Decision date
- 2004-05-19
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR REPLACING THE ICAD SYSTEM'S CAD SOFTWARE WITH THE SECOND LOOK CAD SOFTWARE AND INCREASING THE SYSTEM MEMORY FROM 1 GIGABYTE TO 2 GIGABYTES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK 200 AND IS INDICATED FOR: SECOND LOOK IS A COMPUTED SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDING VIEWS FROM PATIENTS WITH BREAST IMPLANTS AND IMAGES FROM QUALIFIED FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS, TO BRING TO TH
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| Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) | Icad, Inc. | 2016-02-25 |
| AXXENT CERVICAL APPLICATOR (K141343) | Icad, Inc. | 2014-09-05 |