Product code IYT— Radiology

FDA has cleared 49 devices under product code IYT between 1978 and 2026, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20201 clearance
• 19952 clearances
• 19921 clearance
• 19914 clearances
• 19906 clearances
• 19883 clearances
• 19872 clearances
• 19867 clearances
• 198514 clearances
• 19842 clearances
• 19822 clearances
• 19812 clearances
• 19782 clearances

• Medipart Jerry Alexander23 clearances
• Amici, Inc.5 clearances
• Medi Nuclear Corp., Inc.3 clearances
• Vital Signs, Inc.2 clearances
• Mallinckrodt Critical Care2 clearances
• Tetley Medical , Ltd.1 clearance
• Nuclear Pharmacy, Inc.1 clearance
• Mirion Technologies (Capintec), Inc.1 clearance
• Medi-Physics Inc. Dba Nycomed Amersham Imaging1 clearance
• Marquest Medical Products, Inc.1 clearance

• K253942 — Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc.·2026-07-07
• K200916 — Patient Administration SetCyclomedica Australia Pty, Ltd.·2020-09-01
• K953513 — XENON CIRCUITKing Systems Corp.·1995-11-03
• K952223 — XENON GAS BREATHING CIRCUITIntertech Resources, Inc.·1995-08-11
• K914747 — XENON CIRCUITGibeck, Inc.·1992-02-27
• K913416 — TETLEY PATIENT ADMINISTRATION SETTetley Medical , Ltd.·1991-10-28
• K912626 — BOLUS XENON CIRCUITVital Signs, Inc.·1991-08-02
• K903805 — AMICI XENON ADMINISTRATION SETAmici, Inc.·1991-01-14
• K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONAmici, Inc.·1991-01-14
• K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEAmici, Inc.·1990-10-03
• K896885 — DISPOSABLE RESPIRTORY KIT (MP-200)Medipart Jerry Alexander·1990-02-26
• K896125 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MMedipart Jerry Alexander·1990-02-01
• K896124 — MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133Medipart Jerry Alexander·1990-01-22
• K896475 — DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDMedipart Jerry Alexander·1990-01-22
• K896476 — DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDMedipart Jerry Alexander·1990-01-22
• K881812 — AERO-MIST NEBULIZERCadema Medical Products, Inc.·1988-07-18
• K871868 — VENTI-SCAN IIAtomic Products Corp.·1988-04-11
• K872920 — AMICI KRYPTON ADMINISTRATION SYSTEM*Amici, Inc.·1988-02-12
• K865107 — AERO-VENT AEROSOL UNITMedi Nuclear Corp., Inc.·1987-10-20
• K865084 — AMICI XENON REBREATHING SYSTEM*Amici, Inc.·1987-03-03
• K863996 — MODEL XE-103 XENON/MASTER IIMedi Nuclear Corp., Inc.·1986-11-04
• K863778 — VENTICIS IICis-Us, Inc.·1986-10-27
• K862791 — MP-30XM-IE FACE MASK AND FILTER KITMedipart Jerry Alexander·1986-08-01
• K862792 — MP-066 RADIOAEROSOL KITMedipart Jerry Alexander·1986-08-01
• K862793 — MP-066-M RADIOAEROSOL KITMedipart Jerry Alexander·1986-08-01
• K862794 — MP-070 RADIOAEROSOL KITMedipart Jerry Alexander·1986-08-01
• K862795 — MP-070-M RADIOAEROSOL KITMedipart Jerry Alexander·1986-08-01
• K853570 — MEDIPART DRIERITE MP-1002Medipart Jerry Alexander·1985-11-07
• K853576 — MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133MMedipart Jerry Alexander·1985-11-07
• K853579 — MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133Medipart Jerry Alexander·1985-11-07
• K851198 — MEDIPART LUNG AEROSOL KIT MP-1012AMedipart Jerry Alexander·1985-09-10
• K851199 — MEDIPART LUNG AEROSOL KIT MP-1012A-MMedipart Jerry Alexander·1985-09-10
• K851200 — MEDIPART LUNG AEROSOL KIT MP-1024AMedipart Jerry Alexander·1985-09-10
• K851201 — MEDIPART LUND AEROSOL KIT MP-1024A-MMedipart Jerry Alexander·1985-09-10
• K850836 — MEDIPART FACE MASK MP-XM-IMedipart Jerry Alexander·1985-08-19
• K850837 — MEDIPART FACE MASK & FILTER MP-30XM-IMedipart Jerry Alexander·1985-08-19
• K853056 — RESPIR GARD-II FACE MASK CORRUGATED TUBINGMarquest Medical Products, Inc.·1985-08-07
• K852693 — XEN-REX INuclear Pharmacy, Inc.·1985-07-24
• K850366 — MEDIPART XENON BREATHING KIT MP-OIXM-IMedipart Jerry Alexander·1985-04-30
• K850367 — MEDIPART XENON BREATHING KIT MP-02XM-IMedipart Jerry Alexander·1985-04-30
• K843640 — XENON XE 127/XE 133 GAS DISPENSERMallinckrodt Critical Care·1985-01-14
• K844496 — MEDIPART XENON BREATHING KIT MP-01XMMedipart Jerry Alexander·1984-12-24
• K844495 — MEDIPART XENON BREATHING KIT MP-02XMMedipart Jerry Alexander·1984-12-17
• K820571 — XENAMATIC SERIES OF XENON REBREATH DEVDiversified P.A.·1982-03-31
• K820143 — XENON DELIVERY SYSTEMVital Signs, Inc.·1982-03-02
• K811118 — KRYPTON MASKS & TUBINGMedi-Physics Inc. Dba Nycomed Amersham Imaging·1981-06-02
• K810819 — MEDI/NUCLEAR #XE-102 XENON/MASTERMedi Nuclear Corp., Inc.·1981-04-14
• K781933 — DISPENSOR, XENON GASDiagnostic Isotapes, Inc.·1978-12-04
• K781107 — DISPENSER, GAS XENONMallinckrodt Critical Care·1978-07-17