IYZ — Bed, Scanning, Nuclear Class I

FDA Device Classification

FDA product code IYZ covers "Bed, Scanning, Nuclear", a Class I medical device regulated under 21 CFR 892.1350. Submissions are reviewed by the Radiology panel. At least 12 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IYZ
Device Class
Class I
Regulation Number
892.1350
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K920962nu age productsMULTIPLE ACCESSORY TO GAMMA CAMERASApril 17, 1992
K915541atomic productsSPECT TABLE, MODEL #056-760January 17, 1992
K911691med-tron productsXYZ CRANK IMAGING TABLEAugust 9, 1991
K912286siemens gammasonicsCARDIAC SPECT PALLETAugust 2, 1991
K912481siemens gammasonicsECT CARBON FIBER PALLET, MODIFICATIONAugust 2, 1991
K912181med-tron productsE-Z LIFT CRANK IMAGING TABLEJuly 17, 1991
K912135med-tron productsXY IMAGING TABLEJuly 17, 1991
K911561med-tron productsXYZ IMAGING TABLE WITH FOOT PUMPJuly 15, 1991
K911564med-tron productsE-Z LIFT IMAGING TABLE WITH FOOT PUMPJuly 15, 1991
K903901med-tron productsSCANNING COTSeptember 21, 1990
K903767siemens gammasonicsECT (EMMISSION COMPUTED TOMOGRAPHY) CARBON FIB PALSeptember 7, 1990
K893826qrsystemsQRSYSTEMS H.D. NUCLEAR IMAGING TABLEAugust 2, 1989