K260980

cmAngio® V2.0

510(k) number
K260980
Device name
cmAngio® V2.0
Applicant
Curemetrix, Inc. CA · US
Product code
QIH — Automated Radiological Image Processing Software
Decision date
2026-07-30
Date received
2026-03-25
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Radiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260980
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.