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 from Gleamer, filed under MYN, medical image analyzers. The classification record defines the code only by a link to FDA's 2020 reclassification notice for medical image analyzers. The record doesn't describe what ChestView does.

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).

Clearance details

Applicant: Gleamer
Product code: Product 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.