SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
FDA premarket approval P010034/S002 · decided 2003-03-07
Approval details
- PMA number
- P010034
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2002-08-05
- Decision date
- 2003-03-07
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COLORADO MEDTECH, INC., BOULDER, COLORADO.
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510(k) clearances by this applicant
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|---|---|---|
| ProFound Detection (V4.0) (K240417) | Icad, Inc. | 2024-11-08 |
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| ProFound AI Software V3.0 (K203822) | Icad, Inc. | 2021-03-12 |
| ProFound AI Software V2.1 (K191994) | Icad, Inc. | 2019-10-04 |
| PowerLook Tomo Detection V2 Software (K182373) | Icad, Inc. | 2018-12-06 |
| PowerLook Density Assessment Software (K180125) | Icad, Inc. | 2018-04-05 |
| Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570) | Icad, Inc. | 2016-02-25 |
| AXXENT CERVICAL APPLICATOR (K141343) | Icad, Inc. | 2014-09-05 |