IYT
- Product code
- IYT
- Device name
- System, Rebreathing, Radionuclide
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1390
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 49 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253942 | 2026-07-07 | Mirion Technologies (Capintec), Inc. | Pulmonex II Xenon System (132-503) |
Official FDA classification page: IYT
Classification and pathway per current FDA publications. Data from openFDA (CC0).