Pulmonex II Xenon System (132-503)
Device Facts
| Record ID | K253942 |
|---|---|
| Device Name | Pulmonex II Xenon System (132-503) |
| Applicant | Mirion Technologies (Capintec), Inc. |
| Product Code | IYT · Radiology |
| Decision Date | Jul 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1390 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
