Cleerly LABS (v2.0)— 510(k) K242338

Substantially Equivalent

Cleerly, Inc.

FDA 510(k) clearance K242338 for Cleerly LABS (v2.0), Substantially Equivalent on 2025-03-07. Applicant: Cleerly, Inc.. Device class: 2.

Clearance details

Applicant: Cleerly, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-08-07
Decision date: 2025-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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