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IYX — Camera, Scintillation (Gamma) Class I

FDA Device Classification

Classification Details

Product Code
IYX
Device Class
Class I
Regulation Number
892.1100
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230221versant medical physics and radiation safetyQDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular RadiotAugust 28, 2023
K212587radiopharmaceutical imaging and dosimetry3D-RD-SFebruary 22, 2023
K163687hermes medical solutionsOLINDA EXMJuly 19, 2017
K160933ge healthcareDiscovery NM 750b BopsyNovember 18, 2016
K162052general equipment for medical imaging (oncovisionSentinella 102, Sentinella 102 HorusAugust 18, 2016
K143156general equipment for medical imaging (oncovisionSentinella 102; Sentinella 102 HorusNovember 18, 2014
K123408digiradERGO IMAGING SYSTEMJanuary 15, 2013
K111791gamma medica-ideas incorporatedLUMAGEM MOLECULAR BREAST IMAGING SYSTEMSeptember 23, 2011
K110384dilon technologiesDILON 6800 ACELLA (ACELLA)May 3, 2011
K110601general equipment for medical imagingSENTINELLA 102March 18, 2011
K102231ge medical systems israel, functional imagingDISCOVERY NM 750BNovember 3, 2010
K101391scandia corporationSCANDIA-45 GAMMA CAMERA SYSTEMAugust 4, 2010
K100838digiradERGO IMAGING SYSTEMApril 23, 2010
K093706hybridyne imaging technologiesPROXISCAN MODEL 101April 2, 2010
K082588dilon technologiesGAMMALOC SYSTEM, MODEL 03-00001December 11, 2009
K092471general equipment for medical imagingMODEL SENTINELLA 102October 2, 2009
K081757verista imagingVERISTA IMAGING ISOCAM II GAMMA CAMERAAugust 15, 2008
K081829danish diagnostic developmentCAPIMAGEJuly 11, 2008
K073456medxT-QUEST SYSTEMDecember 20, 2007
K071195ani-kal iiKHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5June 20, 2007