IYT

System, Rebreathing, Radionuclide

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)

Last three years. Most recent: 2026-07-07.

NumberDecision dateApplicantDevice nameSummary
K2539422026-07-07Mirion Technologies (Capintec), Inc.Pulmonex II Xenon System (132-503)PDF

1 summaries are archived here for direct download.

Official FDA classification page: IYT
Classification and pathway per current FDA publications. Data from openFDA (CC0).