IYT — System, Rebreathing, Radionuclide Class II

FDA Device Classification

Classification Details

Product Code
IYT
Device Class
Class II
Regulation Number
892.1390
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K200916cyclomedica australia ptyPatient Administration SetSeptember 1, 2020
K953513king systemsXENON CIRCUITNovember 3, 1995
K952223intertech resourcesXENON GAS BREATHING CIRCUITAugust 11, 1995
K914747gibeckXENON CIRCUITFebruary 27, 1992
K913416tetley medicalTETLEY PATIENT ADMINISTRATION SETOctober 28, 1991
K912626vital signsBOLUS XENON CIRCUITAugust 2, 1991
K904684amiciAMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONJanuary 14, 1991
K903805amiciAMICI XENON ADMINISTRATION SETJanuary 14, 1991
K903694amiciAMICI TRU-FIT SOFT PLASTIC MOUTHPIECEOctober 3, 1990
K896885medipart jerry alexanderDISPOSABLE RESPIRTORY KIT (MP-200)February 26, 1990
K896125medipart jerry alexanderMEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MFebruary 1, 1990
K896124medipart jerry alexanderMEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133January 22, 1990
K896475medipart jerry alexanderDISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDJanuary 22, 1990
K896476medipart jerry alexanderDISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDJanuary 22, 1990
K881812cadema medical productsAERO-MIST NEBULIZERJuly 18, 1988
K871868atomic productsVENTI-SCAN IIApril 11, 1988
K872920amiciAMICI KRYPTON ADMINISTRATION SYSTEM*February 12, 1988
K865107medi nuclear corpAERO-VENT AEROSOL UNITOctober 20, 1987
K865084amiciAMICI XENON REBREATHING SYSTEM*March 3, 1987
K863996medi nuclear corpMODEL XE-103 XENON/MASTER IINovember 4, 1986