Cleerly Plaque— 510(k) K261210
Substantially EquivalentCleerly, Inc.
FDA 510(k) clearance K261210 for Cleerly Plaque, Substantially Equivalent on 2026-07-29. Applicant: Cleerly, Inc.. Device class: 2.
Summary
Cleerly Plaque from Cleerly is filed under QIH, automated radiological image processing software. The name refers to plaque, but the record doesn't describe the software's inputs or outputs.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Cleerly filed from Denver, Colorado. Review took 106 calendar days (April 14 to July 29, 2026).
Clearance details
- Applicant
- Cleerly, 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
- Denver, CO, US
Recent devices under product code QIH
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