K242342
- 510(k) number
- K242342
- Device name
- Fetal EchoScan
- Applicant
- Brightheart FR
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2024-11-14
- Date received
- 2024-08-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242342.pdf
Official FDA record: K242342
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.