K251342
- 510(k) number
- K251342
- Device name
- EchoPAC Software Only / EchoPAC Plug-in
- Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics WI · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-07-16
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251342.pdf
Official FDA record: K251342
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.