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IZD — Probe, Uptake, Nuclear Class I

FDA Device Classification

Classification Details

Product Code
IZD
Device Class
Class I
Regulation Number
892.1320
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K133781surgiceyeDECLIPSESPECT LAPAROSCOPYApril 11, 2014
K123917surgiceyeDECLIPSESPECT VIEWERJanuary 25, 2013
K101887surgiceyeCONFIDENT SURGERY SUITE 300, MODEL CSS300March 22, 2011
K013751silicon instruments gmhbHANDHELD GAMMA FINDER (HGF)February 6, 2002
K983768radiation monitoring devicesMODIFICATION TO GAMMA GUIDANCE SYSTEMJuly 2, 1999
K982442care wise medical productsC-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)August 25, 1998
K971167neoprobeNEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESJune 26, 1997
K961321radiation monitoring devicesGAMMA GUIDANCE SYSTEMFebruary 10, 1997
K962319neoprobeNEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIESSeptember 13, 1996
K942580neoprobeNEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESFebruary 9, 1995
K932153biodan medical systemsTHYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROMESeptember 7, 1993
K930962capintec instrumentsCAPTUS 2000 WEL COUNTERMay 18, 1993
K924586capintec instrumentsCAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWAREDecember 3, 1992
K922117care wise medical productsC-TRAK BIOPSY SYSTEMOctober 14, 1992
K915279neoprobeNEOPROBE PORTABLE RADIOSCOPE DETECTORJune 10, 1992
K921428capintec instrumentsCAPTUS 500May 28, 1992
K920115oakfield instrumentsMEDISCINTMarch 30, 1992
K913055atomic productsTHYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900September 6, 1991
K902460oakfield instrumentsCARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)August 28, 1990
K896540nuclear data systemsACCUSPEC THYROID UPTAKE SYSTEM SOFTWAREApril 19, 1990