K252294
- 510(k) number
- K252294
- Device name
- Fetal EchoScan (v1.2)
- Applicant
- Brightheart FR
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2025-12-08
- Date received
- 2025-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252294.pdf
Official FDA record: K252294
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.