K241245
- 510(k) number
- K241245
- Device name
- EchoSolv AS
- Applicant
- Echo IQ, Ltd. AU
- Product code
- POK — Computer-Assisted Diagnostic Software For Lesions Su
- Decision date
- 2024-10-04
- Date received
- 2024-05-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.9 MB · U.S. public domain
Also available from FDA: K241245.pdf
Official FDA record: K241245
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.