FDA Product Code
FDA Product Code IYT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1390
510(k) Clearances — 49 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253942 | Pulmonex II Xenon System (132-503) | Mirion Technologies (Capintec), Inc. | 2026-07-07 | Traditional | PDF ↗ |
| K200916 | Patient Administration Set | Cyclomedica Australia Pty, Ltd. | 2020-09-01 | Traditional | PDF ↗ |
| K953513 | XENON CIRCUIT | King Systems Corp. | 1995-11-03 | Traditional | PDF ↗ |
| K952223 | XENON GAS BREATHING CIRCUIT | Intertech Resources, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K914747 | XENON CIRCUIT | Gibeck, Inc. | 1992-02-27 | Traditional | PDF ↗ |
| K913416 | TETLEY PATIENT ADMINISTRATION SET | Tetley Medical , Ltd. | 1991-10-28 | Traditional | PDF ↗ |
| K912626 | BOLUS XENON CIRCUIT | Vital Signs, Inc. | 1991-08-02 | Traditional | PDF ↗ |
| K904684 | AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION | Amici, Inc. | 1991-01-14 | Traditional | PDF ↗ |
| K903805 | AMICI XENON ADMINISTRATION SET | Amici, Inc. | 1991-01-14 | Traditional | PDF ↗ |
| K903694 | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE | Amici, Inc. | 1990-10-03 | Traditional | PDF ↗ |
| K896885 | DISPOSABLE RESPIRTORY KIT (MP-200) | Medipart Jerry Alexander | 1990-02-26 | Traditional | PDF ↗ |
| K896125 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M | Medipart Jerry Alexander | 1990-02-01 | Traditional | PDF ↗ |
| K896124 | MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133 | Medipart Jerry Alexander | 1990-01-22 | Traditional | PDF ↗ |
| K896476 | DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD | Medipart Jerry Alexander | 1990-01-22 | Traditional | PDF ↗ |
| K896475 | DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD | Medipart Jerry Alexander | 1990-01-22 | Traditional | PDF ↗ |
| K881812 | AERO-MIST NEBULIZER | Cadema Medical Products, Inc. | 1988-07-18 | Traditional | PDF ↗ |
| K871868 | VENTI-SCAN II | Atomic Products Corp. | 1988-04-11 | Traditional | PDF ↗ |
| K872920 | AMICI KRYPTON ADMINISTRATION SYSTEM* | Amici, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K865107 | AERO-VENT AEROSOL UNIT | Medi Nuclear Corp., Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K865084 | AMICI XENON REBREATHING SYSTEM* | Amici, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K863996 | MODEL XE-103 XENON/MASTER II | Medi Nuclear Corp., Inc. | 1986-11-04 | Traditional | PDF ↗ |
| K863778 | VENTICIS II | Cis-Us, Inc. | 1986-10-27 | Traditional | PDF ↗ |
| K862793 | MP-066-M RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | Traditional | PDF ↗ |
| K862791 | MP-30XM-IE FACE MASK AND FILTER KIT | Medipart Jerry Alexander | 1986-08-01 | Traditional | PDF ↗ |
| K862792 | MP-066 RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | Traditional | PDF ↗ |
| K862794 | MP-070 RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | Traditional | PDF ↗ |
| K862795 | MP-070-M RADIOAEROSOL KIT | Medipart Jerry Alexander | 1986-08-01 | Traditional | PDF ↗ |
| K853576 | MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M | Medipart Jerry Alexander | 1985-11-07 | Traditional | PDF ↗ |
| K853579 | MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133 | Medipart Jerry Alexander | 1985-11-07 | Traditional | PDF ↗ |
| K853570 | MEDIPART DRIERITE MP-1002 | Medipart Jerry Alexander | 1985-11-07 | Traditional | PDF ↗ |
| K851201 | MEDIPART LUND AEROSOL KIT MP-1024A-M | Medipart Jerry Alexander | 1985-09-10 | Traditional | PDF ↗ |
| K851200 | MEDIPART LUNG AEROSOL KIT MP-1024A | Medipart Jerry Alexander | 1985-09-10 | Traditional | PDF ↗ |
| K851198 | MEDIPART LUNG AEROSOL KIT MP-1012A | Medipart Jerry Alexander | 1985-09-10 | Traditional | PDF ↗ |
| K851199 | MEDIPART LUNG AEROSOL KIT MP-1012A-M | Medipart Jerry Alexander | 1985-09-10 | Traditional | PDF ↗ |
| K850837 | MEDIPART FACE MASK & FILTER MP-30XM-I | Medipart Jerry Alexander | 1985-08-19 | Traditional | PDF ↗ |
| K850836 | MEDIPART FACE MASK MP-XM-I | Medipart Jerry Alexander | 1985-08-19 | Traditional | PDF ↗ |
| K853056 | RESPIR GARD-II FACE MASK CORRUGATED TUBING | Marquest Medical Products, Inc. | 1985-08-07 | Traditional | PDF ↗ |
| K852693 | XEN-REX I | Nuclear Pharmacy, Inc. | 1985-07-24 | Traditional | PDF ↗ |
| K850367 | MEDIPART XENON BREATHING KIT MP-02XM-I | Medipart Jerry Alexander | 1985-04-30 | Traditional | PDF ↗ |
| K850366 | MEDIPART XENON BREATHING KIT MP-OIXM-I | Medipart Jerry Alexander | 1985-04-30 | Traditional | PDF ↗ |
| K843640 | XENON XE 127/XE 133 GAS DISPENSER | Mallinckrodt Critical Care | 1985-01-14 | Traditional | PDF ↗ |
| K844496 | MEDIPART XENON BREATHING KIT MP-01XM | Medipart Jerry Alexander | 1984-12-24 | Traditional | PDF ↗ |
| K844495 | MEDIPART XENON BREATHING KIT MP-02XM | Medipart Jerry Alexander | 1984-12-17 | Traditional | PDF ↗ |
| K820571 | XENAMATIC SERIES OF XENON REBREATH DEV | Diversified P.A. | 1982-03-31 | Traditional | PDF ↗ |
| K820143 | XENON DELIVERY SYSTEM | Vital Signs, Inc. | 1982-03-02 | Traditional | PDF ↗ |
| K811118 | KRYPTON MASKS & TUBING | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-06-02 | Traditional | PDF ↗ |
| K810819 | MEDI/NUCLEAR #XE-102 XENON/MASTER | Medi Nuclear Corp., Inc. | 1981-04-14 | Traditional | PDF ↗ |
| K781933 | DISPENSOR, XENON GAS | Diagnostic Isotapes, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781107 | DISPENSER, GAS XENON | Mallinckrodt Critical Care | 1978-07-17 | Traditional | PDF ↗ |
Product code IYT · Class II · Radiology. Data: openFDA.