System, Rebreathing, Radionuclide
FDA product code IYT · Class II (moderate risk) · 21 CFR 892.1390 · Radiology
49510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Medipart Jerry Alexander 23
- Amici, Inc. 5
- Medi Nuclear Corp., Inc. 3
- Vital Signs, Inc. 2
- Mallinckrodt Critical Care 2
- Cis-Us, Inc. 1
- Mirion Technologies (Capintec), Inc. 1
- Cyclomedica Australia Pty, Ltd. 1
- King Systems Corp. 1
- Intertech Resources, Inc. 1
- Gibeck, Inc. 1
- Tetley Medical , Ltd. 1
- Cadema Medical Products, Inc. 1
- Atomic Products Corp. 1
- Marquest Medical Products, Inc. 1
- Nuclear Pharmacy, Inc. 1
- Diversified P.A. 1
- Medi-Physics Inc. Dba Nycomed Amersham Imaging 1
- Diagnostic Isotapes, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253942 | Pulmonex II Xenon System (132-503)IYT · Traditional | Mirion Technologies (Capintec), Inc. | 07/07/2026SE |
| K200916 | Patient Administration SetIYT · Traditional | Cyclomedica Australia Pty, Ltd. | 09/01/2020SE |
| K953513 | Xenon CircuitIYT · Traditional | King Systems Corp. | 11/03/1995SE |
| K952223 | Xenon Gas Breathing CircuitIYT · Traditional | Intertech Resources, Inc. | 08/11/1995SE |
| K914747 | Xenon CircuitIYT · Traditional | Gibeck, Inc. | 02/27/1992SE |
| K913416 | Tetley Patient Administration SetIYT · Traditional | Tetley Medical , Ltd. | 10/28/1991SE |
| K912626 | Bolus Xenon CircuitIYT · Traditional | Vital Signs, Inc. | 08/02/1991SE |
| K904684 | Amici Krypton Administration System, ModificationIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903805 | Amici Xenon Administration SetIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903694 | Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional | Amici, Inc. | 10/03/1990SE |
| K896885 | Disposable Respirtory Kit (MP-200)IYT · Traditional | Medipart Jerry Alexander | 02/26/1990SE |
| K896125 | Medipart Disposable XENON-133 Rebreathing MP-0133MIYT · Traditional | Medipart Jerry Alexander | 02/01/1990SE |
| K896476 | Disp. Radioaerosol Kit (MP-400-M) to Fit ShieldIYT · Traditional | Medipart Jerry Alexander | 01/22/1990SE |
| K896475 | Disp. Radioaerosol Kit (MP-400) to Fit Lead ShieldIYT · Traditional | Medipart Jerry Alexander | 01/22/1990SE |
| K896124 | Medipart Disposable XENON-133 Rebreathing MP-0133IYT · Traditional | Medipart Jerry Alexander | 01/22/1990SE |
| K881812 | Aero-Mist NebulizerIYT · Traditional | Cadema Medical Products, Inc. | 07/18/1988SE |
| K871868 | Venti-Scan IIIYT · Traditional | Atomic Products Corp. | 04/11/1988SE |
| K872920 | Amici Krypton Administration System*IYT · Traditional | Amici, Inc. | 02/12/1988SE |
| K865107 | Aero-Vent Aerosol UnitIYT · Traditional | Medi Nuclear Corp., Inc. | 10/20/1987SE |
| K865084 | Amici Xenon Rebreathing System*IYT · Traditional | Amici, Inc. | 03/03/1987SE |
| K863996 | Model XE-103 Xenon/Master IIIYT · Traditional | Medi Nuclear Corp., Inc. | 11/04/1986SE |
| K863778 | Venticis IIIYT · Traditional | Cis-Us, Inc. | 10/27/1986SE |
| K862795 | MP-070-M Radioaerosol KitIYT · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862794 | MP-070 Radioaerosol KitIYT · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862793 | MP-066-M Radioaerosol KitIYT · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862792 | MP-066 Radioaerosol KitIYT · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K862791 | MP-30XM-IE Face Mask and Filter KitIYT · Traditional | Medipart Jerry Alexander | 08/01/1986SE |
| K853579 | Medipart Dispos. Xenon 133 Admin. Sys MP-0133IYT · Traditional | Medipart Jerry Alexander | 11/07/1985SE |
| K853576 | Medipart Dispos. Xenon 133 Admin. Set MP-0133MIYT · Traditional | Medipart Jerry Alexander | 11/07/1985SE |
| K853570 | Medipart Drierite MP-1002IYT · Traditional | Medipart Jerry Alexander | 11/07/1985SE |
| K851201 | Medipart Lund Aerosol Kit MP-1024A-MIYT · Traditional | Medipart Jerry Alexander | 09/10/1985SE |
| K851200 | Medipart Lung Aerosol Kit MP-1024AIYT · Traditional | Medipart Jerry Alexander | 09/10/1985SE |
| K851199 | Medipart Lung Aerosol Kit MP-1012A-MIYT · Traditional | Medipart Jerry Alexander | 09/10/1985SE |
| K851198 | Medipart Lung Aerosol Kit MP-1012AIYT · Traditional | Medipart Jerry Alexander | 09/10/1985SE |
| K850837 | Medipart Face Mask & Filter MP-30XM-IIYT · Traditional | Medipart Jerry Alexander | 08/19/1985SE |
| K850836 | Medipart Face Mask Mp-Xm-IIYT · Traditional | Medipart Jerry Alexander | 08/19/1985SE |
| K853056 | Respir Gard-Ii Face Mask Corrugated TubingIYT · Traditional | Marquest Medical Products, Inc. | 08/07/1985SE |
| K852693 | Xen-Rex IIYT · Traditional | Nuclear Pharmacy, Inc. | 07/24/1985SE |
| K850367 | Medipart Xenon Breathing Kit MP-02XM-IIYT · Traditional | Medipart Jerry Alexander | 04/30/1985SE |
| K850366 | Medipart Xenon Breathing Kit Mp-Oixm-IIYT · Traditional | Medipart Jerry Alexander | 04/30/1985SE |
| K843640 | Xenon Xe 127/XE 133 Gas DispenserIYT · Traditional | Mallinckrodt Critical Care | 01/14/1985SE |
| K844496 | Medipart Xenon Breathing Kit MP-01XMIYT · Traditional | Medipart Jerry Alexander | 12/24/1984SE |
| K844495 | Medipart Xenon Breathing Kit MP-02XMIYT · Traditional | Medipart Jerry Alexander | 12/17/1984SE |
| K820571 | Xenamatic Series of Xenon Rebreath DevIYT · Traditional | Diversified P.A. | 03/31/1982SE |
| K820143 | Xenon Delivery SystemIYT · Traditional | Vital Signs, Inc. | 03/02/1982SE |
| K811118 | Krypton Masks & TubingIYT · Traditional | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 06/02/1981SE |
| K810819 | Medi/Nuclear #XE-102 Xenon/MasterIYT · Traditional | Medi Nuclear Corp., Inc. | 04/14/1981SE |
| K781933 | Dispensor, Xenon GasIYT · Traditional | Diagnostic Isotapes, Inc. | 12/04/1978SE |
| K781107 | Dispenser, Gas XenonIYT · Traditional | Mallinckrodt Critical Care | 07/17/1978SE |