ICAD SYSTEM
FDA premarket approval P010038/S005 · decided 2003-10-31
Approval details
- PMA number
- P010038
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ICAD SYSTEM
- Generic name
- Analyzer, medical image
- Applicant
- Icad, Inc.
- Date received
- 2003-07-29
- Decision date
- 2003-10-31
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Nashua, NH
- Statement
- APPROVAL FOR 1) AN UPGRADED ALGORITHM FOR THE ICAD SYSTEM, 2) USE OF THE ICAD SYSTEM DIRECTLY WITH IMAGES OBTAINED ON THE FISCHER SENOSCAN FFDM SYSTEM, AND 3) THE NEW INCLUSION OF WOMEN WITH BREAST IMPLANTS IN THE TARGET POPULATION IN THE INDICATIONS FOR USE (IFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ICAD SYSTEM WITH THE FOLLOWING INDICATIONS FOR USE: THE ICAD IS A COMPUTER SYSTEM INTENDED TO IDENTIFY AND MARK REGIONS OF INTEREST ON STANDARD MAMMOGRAPHIC VIEWS, INCLUDI
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 |