cmAngio® (V1.6)— 510(k) K250754

Substantially Equivalent

Curemetrix, Inc.

FDA 510(k) clearance K250754 for cmAngio® (V1.6), Substantially Equivalent on 2025-04-10. Applicant: Curemetrix, Inc.. Device class: 2.

Clearance details

Applicant: Curemetrix, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-03-12
Decision date: 2025-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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