K253942
- 510(k) number
- K253942
- Device name
- Pulmonex II Xenon System (132-503)
- Applicant
- Mirion Technologies (Capintec), Inc. NJ · US
- Product code
- IYT — System, Rebreathing, Radionuclide
- Decision date
- 2026-07-07
- Date received
- 2025-12-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253942.pdf
Official FDA record: K253942
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.