ChestView US (1.1)— 510(k) K252486

Name: FDA 510(k) clearance K252486
Creator: U.S. Food and Drug Administration
Published: 2026-09-09

Substantially Equivalent

Gleamer

FDA 510(k) clearance K252486 for ChestView US (1.1), Substantially Equivalent on 2026-09-09. Applicant: Gleamer. Device class: 2.

Summary

ChestView US (version 1.1) is Gleamer's AI software for chest X-rays. Gleamer is a French radiology AI company, best known for its BoneView fracture detection tool. This clearance is filed under MYN, medical image analyzers, the code for software that flags findings on images for a radiologist to review.

Class II, 21 CFR 892.2070. The Radiology panel reviewed it as a Traditional 510(k).

Gleamer filed from Paris, France. Review took 398 days (August 7, 2025 to September 9, 2026). Detection software under this regulation usually needs a reader study showing radiologists do better with the tool, and those studies take time to run.

Clearance details

Applicant: Gleamer
Product code: Code MYN
Device class: Class 2
Regulation: 21 CFR 892.2070
Advisory panel: Radiology
Date received: 2025-08-07
Decision date: 2026-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.