K251071
- 510(k) number
- K251071
- Device name
- Fetal EchoScan (v1.1)
- Applicant
- Brightheart FR
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2025-05-02
- Date received
- 2025-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251071.pdf
Official FDA record: K251071
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.