K250754
- 510(k) number
- K250754
- Device name
- cmAngio® (V1.6)
- Applicant
- Curemetrix, Inc. CA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-04-10
- Date received
- 2025-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250754
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.