SECOND LOOK (TM)
FDA premarket approval P010034 · decided 2002-01-31
Approval details
- PMA number
- P010034
- Trade name
- SECOND LOOK (TM)
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2001-06-11
- Decision date
- 2002-01-31
- Days to decision
- 234 days
- Decision code
- APWD
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE SECOND LOOK. COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS TO BRING THEM TO THE ATTENTION OF THE RADIOLOGIST AFTER THE INITIAL READING HAS BEEN COMPLETED. THUS, THE SYSTEM ASSISTS THE RADIOLOGIST IN MINIMIZING OBSERVATIONAL OVERSIGHTS BY IDENTIFYING AREAS ON THE ORIGINAL MAMMOGRAM THAT MAY WARRANT A SECOND REVIEW.
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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 |