Pulmonex II Xenon System (132-503)— 510(k) K253942

Name: FDA 510(k) clearance K253942
Creator: U.S. Food and Drug Administration
Published: 2026-07-07

Substantially Equivalent

Mirion Technologies (Capintec), Inc.

FDA 510(k) clearance K253942 for Pulmonex II Xenon System (132-503), Substantially Equivalent on 2026-07-07. Applicant: Mirion Technologies (Capintec), Inc.. Device class: 2.

Clearance details

Applicant: Mirion Technologies (Capintec), Inc.
Product code: Code IYT
Device class: Class 2
Regulation: 21 CFR 892.1390
Advisory panel: Radiology
Date received: 2025-12-09
Decision date: 2026-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florham Park, NJ, US

Download summary PDF View on FDA.gov ↗

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