cmAngio® V2.0— 510(k) K260980
Substantially EquivalentCuremetrix, Inc.
FDA 510(k) clearance K260980 for cmAngio® V2.0, Substantially Equivalent on 2026-07-30. Applicant: Curemetrix, Inc.. Device class: 2.
Summary
Curemetrix's cmAngio V2.0 is filed under QIH, automated radiological image processing software. The name carries a version number, and the record doesn't describe what the software processes or outputs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Curemetrix filed from San Diego, California. Review took 127 calendar days (March 25 to July 30, 2026).
Clearance details
- Applicant
- Curemetrix, Inc.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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