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

Substantially Equivalent

Mirion Technologies (Capintec), Inc.

Clearance details

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

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