Product code IYT
- Device name
- System, Rebreathing, Radionuclide
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1390
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200916 | Patient Administration Set | Cyclomedica Australia Pty, Ltd. | 2020-09-01 |
| K953513 | XENON CIRCUIT | King Systems Corp. | 1995-11-03 |
| K952223 | XENON GAS BREATHING CIRCUIT | Intertech Resources, Inc. | 1995-08-11 |
| K914747 | XENON CIRCUIT | Gibeck, Inc. | 1992-02-27 |
| K913416 | TETLEY PATIENT ADMINISTRATION SET | Tetley Medical , Ltd. | 1991-10-28 |
| K912626 | BOLUS XENON CIRCUIT | Vital Signs, Inc. | 1991-08-02 |
| K904684 | AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION | Amici, Inc. | 1991-01-14 |
| K903805 | AMICI XENON ADMINISTRATION SET | Amici, Inc. | 1991-01-14 |
| K903694 | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE | Amici, Inc. | 1990-10-03 |
| K896885 | DISPOSABLE RESPIRTORY KIT (MP-200) | Medipart Jerry Alexander | 1990-02-26 |
| K896125 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M | Medipart Jerry Alexander | 1990-02-01 |
| K896124 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 | Medipart Jerry Alexander | 1990-01-22 |
| K896475 | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD | Medipart Jerry Alexander | 1990-01-22 |
| K896476 | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD | Medipart Jerry Alexander | 1990-01-22 |
| K881812 | AERO-MIST NEBULIZER | Cadema Medical Products, Inc. | 1988-07-18 |
| K871868 | VENTI-SCAN II | Atomic Products Corp. | 1988-04-11 |
| K872920 | AMICI KRYPTON ADMINISTRATION SYSTEM* | Amici, Inc. | 1988-02-12 |
| K865107 | AERO-VENT AEROSOL UNIT | Medi Nuclear Corp., Inc. | 1987-10-20 |
| K865084 | AMICI XENON REBREATHING SYSTEM* | Amici, Inc. | 1987-03-03 |
| K863996 | MODEL XE-103 XENON/MASTER II | Medi Nuclear Corp., Inc. | 1986-11-04 |
| K863778 | VENTICIS II | Cis-Us, Inc. | 1986-10-27 |
| K862795 | MP-070-M RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 |
| K862794 | MP-070 RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 |
| K862793 | MP-066-M RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 |
| K862792 | MP-066 RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 |
| K862791 | MP-30XM-IE FACE MASK AND FILTER KIT | Medipart Jerry Alexander | 1986-08-01 |
| K853579 | MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133 | Medipart Jerry Alexander | 1985-11-07 |
| K853576 | MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M | Medipart Jerry Alexander | 1985-11-07 |
| K853570 | MEDIPART DRIERITE MP-1002 | Medipart Jerry Alexander | 1985-11-07 |
| K851201 | MEDIPART LUND AEROSOL KIT MP-1024A-M | Medipart Jerry Alexander | 1985-09-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00612649200590 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-22 |
| 00612649186122 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186313 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186306 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186290 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186269 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186221 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186214 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186207 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186191 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186184 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186160 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186153 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186146 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186139 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186115 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649186108 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185828 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185811 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185804 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185798 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185781 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185774 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185750 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185743 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185347 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185330 | DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185293 | DISPOSABLE XENON KITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 00612649185279 | DISPOSABLE XENON KITFOR NUCLEAR MEDICINE | King Systems Corporation | 2016-09-21 |
| 10885403296727 | Vital Signs | Carefusion Corporation | 2016-09-01 |