Data / Medical devices / System, Rebreathing, Radionuclide
System, Rebreathing, Radionuclide (IYT): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make System, Rebreathing, Radionuclide (product code IYT, Class 2, 21 CFR 892.1390). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 49 510(k) clearances under this code, the latest on July 7, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IYT
- Device class
- 2
- Regulation
- 892.1390
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Australia | 1 |
| Mexico | 1 |
Makers of System, Rebreathing, Radionuclide
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medi Nuclear Corp., Inc. | Baldwin Park, CA, United States | Manufacturer | 2 | October 20, 1987 | 0 | 0 | 0 | api.fda.gov |
| Cyclomedica Australia Pty Ltd | Kingsgrove New South Wales, Australia | Manufacturer | 1 | September 1, 2020 | 0 | 0 | 0 | api.fda.gov |
| Curium US LLC | Maryland Heights, MO, United States | Complaint file establishment, Specification developer | 1 | January 14, 1985 | 0 | 0 | 0 | api.fda.gov |
| King Systems Corporation. | Noblesville, IN, United States | Manufacturer, Repackager or relabeler | 1 | November 3, 1995 | 0 | 0 | 0 | api.fda.gov |
| Mirion Technologies (capintec), Inc | Florham Park, NJ, United States | Manufacturer | 1 | April 11, 1988 | 0 | 0 | 0 | api.fda.gov |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 1 | March 2, 1982 | 0 | 0 | 0 | api.fda.gov |
| Radnostix | Idaho Falls, ID, United States | Specification developer | 1 | October 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | March 2, 1982 | 0 | 0 | 0 | api.fda.gov |
| Mallinckrodt Manufacturing LLC | Madison, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tricor Systems | Elgin, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.