510(k) K253942 ยท IYT System, Rebreathing, Radionuclide
Pulmonex II Xenon System (132-503)
| Applicant | Mirion Technologies (Capintec), Inc., Florham Park NJ, US |
| Decision | Substantially Equivalent, Jul 7, 2026 |
| Received | Dec 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253942
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.