FDA 510(k) clearance · back to tracker

Pulmonex II Xenon System (132-503)

Mirion Technologies (Capintec), Inc. cleared K253942 on 2026-07-07, decision: substantially equivalent

K-number

K253942

Sponsor

Mirion Technologies (Capintec), Inc.

Device

Pulmonex II Xenon System (132-503)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-07

Product code

IYT

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1390

Official FDA record

Open K253942on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.