IYT — System, Rebreathing, Radionuclide Class II
FDA product code IYT covers "System, Rebreathing, Radionuclide", a Class II medical device regulated under 21 CFR 892.1390. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IYT
- Device Class
- Class II
- Regulation Number
- 892.1390
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253942 | mirion technologies (capintec) | Pulmonex II Xenon System (132-503) | July 7, 2026 |
| K200916 | cyclomedica australia pty | Patient Administration Set | September 1, 2020 |
| K953513 | king systems | XENON CIRCUIT | November 3, 1995 |
| K952223 | intertech resources | XENON GAS BREATHING CIRCUIT | August 11, 1995 |
| K914747 | gibeck | XENON CIRCUIT | February 27, 1992 |
| K913416 | tetley medical | TETLEY PATIENT ADMINISTRATION SET | October 28, 1991 |
| K912626 | vital signs | BOLUS XENON CIRCUIT | August 2, 1991 |
| K903805 | amici | AMICI XENON ADMINISTRATION SET | January 14, 1991 |
| K904684 | amici | AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION | January 14, 1991 |
| K903694 | amici | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE | October 3, 1990 |
| K896885 | medipart jerry alexander | DISPOSABLE RESPIRTORY KIT (MP-200) | February 26, 1990 |
| K896125 | medipart jerry alexander | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M | February 1, 1990 |
| K896124 | medipart jerry alexander | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 | January 22, 1990 |
| K896476 | medipart jerry alexander | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD | January 22, 1990 |
| K896475 | medipart jerry alexander | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD | January 22, 1990 |
| K881812 | cadema medical products | AERO-MIST NEBULIZER | July 18, 1988 |
| K871868 | atomic products | VENTI-SCAN II | April 11, 1988 |
| K872920 | amici | AMICI KRYPTON ADMINISTRATION SYSTEM* | February 12, 1988 |
| K865107 | medi nuclear corp | AERO-VENT AEROSOL UNIT | October 20, 1987 |
| K865084 | amici | AMICI XENON REBREATHING SYSTEM* | March 3, 1987 |