IYT · System, Rebreathing, Radionuclide
Radiology · 21 CFR 892.1390 · Class 2
Overview
| Product Code | IYT |
|---|---|
| Device Name | System, Rebreathing, Radionuclide |
| Regulation | 21 CFR 892.1390 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200916 | Patient Administration Set | Cyclomedica Australia Pty, Ltd. | Sep 1, 2020 | SESE |
| K953513 | XENON CIRCUIT | King Systems Corp. | Nov 3, 1995 | SESE |
| K952223 | XENON GAS BREATHING CIRCUIT | Intertech Resources, Inc. | Aug 11, 1995 | SESE |
| K914747 | XENON CIRCUIT | Gibeck, Inc. | Feb 27, 1992 | SESE |
| K913416 | TETLEY PATIENT ADMINISTRATION SET | Tetley Medical , Ltd. | Oct 28, 1991 | SESE |
| K912626 | BOLUS XENON CIRCUIT | Vital Signs, Inc. | Aug 2, 1991 | SESE |
| K904684 | AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION | Amici, Inc. | Jan 14, 1991 | SESE |
| K903805 | AMICI XENON ADMINISTRATION SET | Amici, Inc. | Jan 14, 1991 | SESE |
| K903694 | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE | Amici, Inc. | Oct 3, 1990 | SESE |
| K896885 | DISPOSABLE RESPIRTORY KIT (MP-200) | Medipart Jerry Alexander | Feb 26, 1990 | SESE |
| K896125 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M | Medipart Jerry Alexander | Feb 1, 1990 | SESE |
| K896476 | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD | Medipart Jerry Alexander | Jan 22, 1990 | SESE |
| K896475 | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD | Medipart Jerry Alexander | Jan 22, 1990 | SESE |
| K896124 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 | Medipart Jerry Alexander | Jan 22, 1990 | SESE |
| K881812 | AERO-MIST NEBULIZER | Cadema Medical Products, Inc. | Jul 18, 1988 | SESE |
| K871868 | VENTI-SCAN II | Atomic Products Corp. | Apr 11, 1988 | SESE |
| K872920 | AMICI KRYPTON ADMINISTRATION SYSTEM* | Amici, Inc. | Feb 12, 1988 | SESE |
| K865107 | AERO-VENT AEROSOL UNIT | Medi Nuclear Corp., Inc. | Oct 20, 1987 | SESE |
| K865084 | AMICI XENON REBREATHING SYSTEM* | Amici, Inc. | Mar 3, 1987 | SESE |
| K863996 | MODEL XE-103 XENON/MASTER II | Medi Nuclear Corp., Inc. | Nov 4, 1986 | SESE |
Top Applicants
- Medipart Jerry Alexander — 23 clearances
- Amici, Inc. — 5 clearances
- Medi Nuclear Corp., Inc. — 3 clearances
- Vital Signs, Inc. — 2 clearances
- Mallinckrodt Critical Care — 2 clearances
