ProFound Detection (V4.0)
FDA 510(k) clearance K240417 · decided 2024-11-08
Clearance details
- K-number
- K240417
- Device name
- ProFound Detection (V4.0)
- Applicant
- Icad, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-13
- Decision date
- 2024-11-08
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- QDQ
- Device class
- 2
- Regulation number
- 892.2090
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Nashua, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PowerLook® Tomo Detection Software (P160009) | Icad, Inc. | 2017-03-24 |
| M-VU ALGORITHM ENGINE (P100005/S007) | Icad, Inc. | 2017-01-11 |
| M-VU ALGORITHM ENGINE (P100005/S005) | Icad, Inc. | 2015-03-02 |
| M-VU ALGORITHM ENGINE (P100005/S004) | Icad, Inc. | 2014-06-06 |
| M-VU ALGORITHM ENGINE (P100005/S003) | Icad, Inc. | 2013-12-02 |
| M-VU ALGORITHM ENGINE (P100005/S002) | Icad, Inc. | 2013-06-19 |
| SECONDLOOK DIGITAL (P010038/S017) | Icad, Inc. | 2013-06-19 |
| SECONDLOOK DIGITAL V7.2 CAD (P010038/S016) | Icad, Inc. | 2012-11-09 |