K250288
- 510(k) number
- K250288
- Device name
- TeraRecon Cardiovascular.Calcification.CT
- Applicant
- Terarecon,Inc. NC · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-10-23
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250288.pdf
Official FDA record: K250288
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.