SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
FDA premarket approval P010038/S008 · decided 2004-09-01
Approval details
- PMA number
- P010038
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2004-06-24
- Decision date
- 2004-09-01
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR THE USE OF THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM WITH THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM AND IS INDICATED FOR: THE SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM IS INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON SCREENING AND DIAGNOSTIC MAMMOGRAMS FROM THE HOLOGIC LORAD SELENIA FULL-FIELD DIGITAL MAMMOGRAPHIC S
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ProFound Detection (V4.0) (K240417) | Icad, Inc. | 2024-11-08 |
| PowerLook Density Assessment V4.0 (K211506) | Icad, Inc. | 2021-07-12 |
| 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 |