K251071 is an FDA 510(k) clearance for the Fetal EchoScan (v1.1). This device is classified as a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II - Special Controls, product code POK).
Submitted by Brightheart (Paris, FR). The FDA issued a Cleared decision on May 2, 2025, 25 days after receiving the submission on April 7, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2060. Assist Users In Characterizing Lesions Identified On Acquired Medical Images.
| 510(k) Number | K251071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2025 |
| Decision Date | May 02, 2025 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | POK - Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2060 |
| Definition | Assist Users In Characterizing Lesions Identified On Acquired Medical Images |