FDA 510(k) Applications for Medical Device Product Code: IYX (Camera, Scintillation (Gamma))

FDA 510(k) Applications for Medical Device Product Code "IYX"
(Camera, Scintillation (Gamma))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K040587	ACRORAD CO., LTD.	MINI GAMMA CAMERA, MODEL MGC-500	05/14/2004
K071195	ANI-KAL II, LLC	KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5	06/20/2007
K022342	ANZAI MEDICAL CO, LTD.	EZ-SCOPE AN, EZ-SCOPE LIGHT	10/09/2002
K062141	BIOLUCENT, INC.	MAMMOPAD RADIOLUCENT CUSHION	09/13/2006
K081829	DANISH DIAGNOSTIC DEVELOPMENT A/S	CAPIMAGE	07/11/2008
K100838	DIGIRAD CORP.	ERGO IMAGING SYSTEM	04/23/2010
K123408	DIGIRAD CORP.	ERGO IMAGING SYSTEM	01/15/2013
K961104	DIGIRAD CORP.	NOTEBOOK IMAGER	05/28/1997
K082588	DILON TECHNOLOGIES LLC	GAMMALOC SYSTEM, MODEL 03-00001	12/11/2009
K984466	DILON TECHNOLOGIES, INC.	DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5	03/16/1999
K110384	DILON TECHNOLOGIES, INC.	DILON 6800 ACELLA (ACELLA)	05/03/2011
K993813	GAMMA MEDICA	LUMAGEM SCINTILLATION CAMERA	01/18/2000
K111791	GAMMA MEDICA-IDEAS INCORPORATED	LUMAGEM MOLECULAR BREAST IMAGING SYSTEM	09/23/2011
K160933	GE Healthcare	Discovery NM 750b Bopsy	11/18/2016
K102231	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	DISCOVERY NM 750B	11/03/2010
K162052	GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-	Sentinella 102, Sentinella 102 Horus	08/18/2016
K143156	GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-	Sentinella 102; Sentinella 102 Horus	11/18/2014
K092471	GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A	MODEL SENTINELLA 102	10/02/2009
K110601	GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A	SENTINELLA 102	03/18/2011
K023373	GVI TECHNOLOGY PARTNERS	ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101	01/03/2003
K051402	GVI TECHNOLOGY PARTNERS	ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM	06/13/2005
K020643	HEALTH POLICY RESORTERS GROUP, LLC	EZ-SCOPE AN & EZ-SCOPE AN LITE	05/28/2002
K163687	Hermes Medical Solutions AB	OLINDA EXM	07/19/2017
K093706	HYBRIDYNE IMAGING TECHNOLOGIES, INC	PROXISCAN MODEL 101	04/02/2010
K052473	INTER MEDICAL MEDIZINTECHNIK GMBH	CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000	10/28/2005
K073456	MEDX, INC.	T-QUEST SYSTEM	12/20/2007
K003775	PEM TECHNOLOGIES	PORTABLE BREAST COMPRESSION DEVICE	01/12/2001
K212587	Radiopharmaceutical Imaging and Dosimetry, LLC	3D-RD-S	02/22/2023
K101391	SCANDIA CORPORATION	SCANDIA-45 GAMMA CAMERA SYSTEM	08/04/2010
K033960	VANDERBILT UNIVERSITY	OLINDA/EXM	06/15/2004
K081757	VERISTA IMAGING INC.	VERISTA IMAGING ISOCAM II GAMMA CAMERA	08/15/2008
K230221	Versant Medical Physics and Radiation Safety	QDOSE« Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)	08/28/2023

FDA 510(k) Applications for Medical Device Product Code "IYX" (Camera, Scintillation (Gamma))

FDA 510(k) Applications for Medical Device Product Code "IYX"
(Camera, Scintillation (Gamma))