Product Code: IYX FDA class 1 21 CFR 892.1100

Camera, Scintillation (Gamma)

Radiology

A gamma scintillation camera, also known as an Anger camera, detects gamma rays emitted from radionuclides administered to patients and creates planar scintigraphic images used to evaluate organ function and identify disease. It is classified as FDA Class 1, reflecting minimal regulatory burden with only general controls required and no premarket notification. The product code is IYX, regulated under 21 CFR 892.1100, within the Radiology medical specialty. This device is eligible for third-party review.

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510(k)s

130

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: IYX
Device Class: FDA class 1
Regulation Number: 892.1100
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 130 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230221	QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)	Aug 28, 2023	Substantially Equivalent	Versant Medical Physics and Radiation Safety
K212587	3D-RD-S	Feb 22, 2023	Substantially Equivalent	Radiopharmaceutical Imaging and Dosimetry, LLC
K163687	OLINDA EXM	Jul 19, 2017	Substantially Equivalent	Hermes Medical Solutions AB
K160933	Discovery NM 750b Bopsy	Nov 18, 2016	Substantially Equivalent	GE Healthcare
K162052	Sentinella 102, Sentinella 102 Horus	Aug 18, 2016	Substantially Equivalent	General Equipment For Medical Imaging (Oncovision-
K143156	Sentinella 102; Sentinella 102 Horus	Nov 18, 2014	Substantially Equivalent	General Equipment For Medical Imaging (Oncovision-
K123408	ERGO IMAGING SYSTEM	Jan 15, 2013	Substantially Equivalent	Digirad Corp.
K111791	LUMAGEM MOLECULAR BREAST IMAGING SYSTEM	Sep 23, 2011	Substantially Equivalent	Gamma Medica-Ideas Incorporated
K110384	DILON 6800 ACELLA (ACELLA)	May 03, 2011	Substantially Equivalent	Dilon Technologies, Inc.
K110601	SENTINELLA 102	Mar 18, 2011	Substantially Equivalent	General Equipment For Medical Imaging, S.A.
K102231	DISCOVERY NM 750B	Nov 03, 2010	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging
K101391	SCANDIA-45 GAMMA CAMERA SYSTEM	Aug 04, 2010	Substantially Equivalent	Scandia Corporation
K100838	ERGO IMAGING SYSTEM	Apr 23, 2010	Substantially Equivalent	Digirad Corp.
K093706	PROXISCAN MODEL 101	Apr 02, 2010	Substantially Equivalent	Hybridyne Imaging Technologies, Inc.
K082588	GAMMALOC SYSTEM, MODEL 03-00001	Dec 11, 2009	Substantially Equivalent	Dilon Technologies, LLC
K092471	MODEL SENTINELLA 102	Oct 02, 2009	Substantially Equivalent	General Equipment For Medical Imaging, S.A.
K081757	VERISTA IMAGING ISOCAM II GAMMA CAMERA	Aug 15, 2008	Substantially Equivalent	Verista Imaging, Inc.
K081829	CAPIMAGE	Jul 11, 2008	Substantially Equivalent	Danish Diagnostic Development A/S
K073456	T-QUEST SYSTEM	Dec 20, 2007	Substantially Equivalent	Medx, Inc.
K071195	KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5	Jun 20, 2007	Substantially Equivalent	Ani-Kal Ii, LLC
K062141	MAMMOPAD RADIOLUCENT CUSHION	Sep 13, 2006	Substantially Equivalent	Biolucent, Inc.
K052473	CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000	Oct 28, 2005	Substantially Equivalent	Inter Medical Medizintechnik GmbH
K051402	ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM	Jun 13, 2005	Substantially Equivalent	Gvi Technology Partners
K033960	OLINDA/EXM	Jun 15, 2004	Substantially Equivalent	Vanderbilt University
K040587	MINI GAMMA CAMERA, MODEL MGC-500	May 14, 2004	Substantially Equivalent	Acrorad Co., Ltd.
K023373	ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101	Jan 03, 2003	Substantially Equivalent	Gvi Technology Partners
K022342	EZ-SCOPE AN, EZ-SCOPE LIGHT	Oct 09, 2002	Substantially Equivalent	Anzai Medical Co., Ltd.
K020643	EZ-SCOPE AN & EZ-SCOPE AN LITE	May 28, 2002	Substantially Equivalent	Health Policy Resorters Group, LLC
K003775	PORTABLE BREAST COMPRESSION DEVICE	Jan 12, 2001	Substantially Equivalent	Pem Technologies
K993813	LUMAGEM SCINTILLATION CAMERA	Jan 18, 2000	Substantially Equivalent	Gamma Medica
K984466	DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5	Mar 16, 1999	Substantially Equivalent	Dilon Technologies, Inc.
K961104	NOTEBOOK IMAGER	May 28, 1997	Substantially Equivalent	Digirad Corp.
K945792	IM512P	May 24, 1995	Substantially Equivalent	Globus Industries
K943602	DI-2000	May 12, 1995	Substantially Equivalent	Miles Inc., Agfa Division
K935273	VISION FX 40 & 80 SERIES GAMMA CAMERA	Apr 18, 1994	Substantially Equivalent	Summit Nuclear
K932701	CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS	Mar 29, 1994	Substantially Equivalent	Nuccardiac Software, Inc.
K934766	CARBON FIBER PALLET	Feb 18, 1994	Substantially Equivalent	Siemens Gammasonics, Inc.
K932673	APEX SPX CARDIAL	Feb 18, 1994	Substantially Equivalent	Elscint, Inc.
K933513	R &D BATTERIES, INC. PART # 5015, 5192, 5482	Nov 24, 1993	Substantially Equivalent	R & D Batteries, Inc.
K933256	FAN BEAM COLLIMATOR	Oct 29, 1993	Substantially Equivalent	Siemens Gammasonics, Inc.
K932957	QUANTEM (TM)	Aug 05, 1993	Substantially Equivalent	GE Medical Systems
K923180	SPECTURN, MODEL TTK-128	Jul 26, 1993	Substantially Equivalent	Harpell Assoc., Inc.
K930283	THYRUS	Jun 21, 1993	Substantially Equivalent	Adac Laboratories
K926550	UNIX-LINK	Mar 18, 1993	Substantially Equivalent	General Electric Co.
K926083	NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES	Feb 12, 1993	Substantially Equivalent	Biodan Medical Systems, Ltd.
K924878	NEW DETECTOR OPTION	Jan 15, 1993	Substantially Equivalent	Adac Laboratories
K924639	NEW DETECTOR FOR TRANSCAM/POLARIS S315	Jan 15, 1993	Substantially Equivalent	Adac Laboratories
K923356	MEDX ROTATIONAL GANTRY SYSTEM	Sep 21, 1992	Substantially Equivalent	Bfi- Medical Waste Systems
K921296	ADAC S315	May 28, 1992	Substantially Equivalent	Adac Laboratories
K910967	NEUROCAM	Jul 03, 1991	Substantially Equivalent	GE Medical Systems
K905074	MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM	Jun 21, 1991	Substantially Equivalent	Siemens Gammasonics, Inc.
K911346	SOPHYCAMERA DSX BODYTRAK	Apr 18, 1991	Substantially Equivalent	Sopha Medical Systems, Inc.
K905412	ES/ULTRA DISPLAY AND PROCESSING STATION	Mar 25, 1991	Substantially Equivalent	Toshiba America Medical Systems, In.C
K903469	GAMMA 600 NUCLEAR MEDICINE COMPUTER	Feb 04, 1991	Substantially Equivalent	Strichman Medical Equipment, Inc.
K905827	FULL VIEW OMEGA TABLE	Jan 28, 1991	Substantially Equivalent	Med-Tron Products, Inc.
K904174	STARCAM 4000	Jan 04, 1991	Substantially Equivalent	General Electric Co.
K904050	MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA	Dec 05, 1990	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K903030	SOPHYCAMERA DSM 315	Oct 29, 1990	Substantially Equivalent	Provino
K903988	PANORAMIC OMEGA IMAGING TABLE	Oct 23, 1990	Substantially Equivalent	Med-Tron Products, Inc.
K900773	NUCLEAR MAX	May 23, 1990	Substantially Equivalent	Scientific Imaging, Inc.
K900689	MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA	Apr 19, 1990	Substantially Equivalent	Adac Laboratories
K894931	SOPHYCAMERA DSX RECTANGULAR	Oct 27, 1989	Substantially Equivalent	Sopha Medical Systems, Inc.
K893379	XENOS MOBILECAM	Aug 11, 1989	Substantially Equivalent	Xenos Medical Systems, Inc.
K885054	SYSTEM SEVENTY SEVEN	Apr 19, 1989	Substantially Equivalent	Scinticor, Inc.
K884675	APEX 609R ANGER CAMERA	Apr 17, 1989	Substantially Equivalent	Elscint, Inc.
K884674	APEX 415 ANGER CAMERA	Apr 17, 1989	Substantially Equivalent	Elscint, Inc.
K884672	APEX 115 NUCLEAR MEDICINE PROCESSOR	Apr 17, 1989	Substantially Equivalent	Elscint, Inc.
K884673	APEX 215M MOBILE ANGER CAMERA	Apr 14, 1989	Substantially Equivalent	Elscint, Inc.
K884661	D-SCOPE III	Apr 12, 1989	Substantially Equivalent	Medx, Inc.
K885242	MICRODELTA II	Mar 30, 1989	Substantially Equivalent	Siemens Gammasonics, Inc.
K880878	CX250 MOBILE GAMMA CAMERA & DCS CONSOLE	Sep 01, 1988	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K881013	MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A	Aug 29, 1988	Substantially Equivalent	Toshiba Medical Systems
K882312	MODEL 3000 NUCLEAR CAMERA	Jul 14, 1988	Substantially Equivalent	Ohio Imaging, Inc.
K875198	DIGITAL NUCLEAR IMAGING SYSTEM	Jul 01, 1988	Substantially Equivalent	Medasys, Inc.
K872297	DS-7 NUCLEAR MEDICINE GAMMA CAMERA	Aug 12, 1987	Substantially Equivalent	Sopha Medical Systems, Inc.
K872127	D-SCOPE II AND D-SCOPE IIC	Jun 18, 1987	Substantially Equivalent	Medx, Inc.
K871175	JUMBO DIGITAL GAMMACAMERA, GCA-901A	Mar 31, 1987	Substantially Equivalent	Toshiba Medical Systems
K870818	BODYSCAN	Mar 16, 1987	Substantially Equivalent	Siemens Gammasonics, Inc.
K870703	SKAN D-SCOPE	Feb 26, 1987	Substantially Equivalent	Medx, Inc.
K861637	WEIGHTED ACQUISITION MODULE	Jun 10, 1986	Substantially Equivalent	Siemens Gammasonics, Inc.
K852648	STARPORT MODEL H3300AA	Jan 30, 1986	Substantially Equivalent	General Electric Co.
K853482	ACE COMPUTER SYSTEM	Jan 01, 1986	Substantially Equivalent	Cardiac Medical Systems Corp.
K853470	JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2	Nov 19, 1985	Substantially Equivalent	Toshiba Medical Systems
K852089	SATURN NUCLEAR MEDICINE COMPUTER SYSTEM	Jul 18, 1985	Substantially Equivalent	Technicare Corp.
K851644	SPECTRUM 150 DT	May 21, 1985	Substantially Equivalent	Raytheon Medical Systems
K850463	BASICAM COUNTER BALANCE CAMERA	Apr 10, 1985	Substantially Equivalent	Siemens Gammasonics, Inc.
K850397	ORBITOR II COUNTER BALANCE CAMERA	Mar 26, 1985	Substantially Equivalent	Siemens Gammasonics, Inc.
K844218	TOMOGRAPHIC GANTRY	Mar 01, 1985	Substantially Equivalent	General Electric Co.
K843716	NUCLEAR 700 MEDICINE MECHANICAL POSIT-	Dec 17, 1984	Substantially Equivalent	Technicare Corp.
K843558	DELTANODE, MEGA DELTA, DELTA LINK-	Nov 13, 1984	Substantially Equivalent	Computer Design & Applications, Inc.
K843288	KETRONIC MEDAX - N	Nov 08, 1984	Substantially Equivalent	Ketronic, Inc.
K841964	MICRO DELTA & CELTAPRO	Aug 21, 1984	Substantially Equivalent	Computer Design & Applications, Inc.
K841906	MAXICAMERA 400 AC	Jul 06, 1984	Substantially Equivalent	General Electric Co.
K840052	DIGITAL PROCESSING SYSTEM	Mar 22, 1984	Substantially Equivalent	Adac Laboratories
K833821	INTERAD 520	Jan 13, 1984	Substantially Equivalent	Interad Systems, Inc.
K833811	CARDIAC CAMERA	Dec 27, 1983	Substantially Equivalent	Siemens Gammasonics, Inc.
K832505	IMAGE PROCESSING SYS A3	Sep 12, 1983	Substantially Equivalent	Metronic, Inc.
K820244	ADD'L TERMINAL SUPPORT FOR STAR BASIC	Mar 02, 1982	Substantially Equivalent	General Electric Co.
K813073	OMEGA 500 RECTANGULAR FIELD CAMERA W/SC	Dec 08, 1981	Substantially Equivalent	Technicare Corp.
K811629	DYNA- MO	Sep 08, 1981	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K811715	ROTA CAMERA	Jul 20, 1981	Substantially Equivalent	Siemens Gammasonics, Inc.
K811676	MAXI CAMERA/D	Jul 02, 1981	Substantially Equivalent	General Electric Co.
K811187	MEDTRONIC A2 CLINICAL IMAGING SYSTEM	May 27, 1981	Substantially Equivalent	Medtronic Vascular
K810974	GAMMA CAMERA	May 13, 1981	Substantially Equivalent	Siemens Gammasonics, Inc.
K802475	A2 IMAGE PROCESSING SYSTEM	Nov 26, 1980	Substantially Equivalent	Medtronic Vascular
K801654	MAXI CAMERA 61	Aug 20, 1980	Substantially Equivalent	General Electric Co.
K801653	MAXI CAMERA 37	Aug 20, 1980	Substantially Equivalent	General Electric Co.
K801368	A2 IMAGE PROCESSING SYSTEM	Jul 21, 1980	Substantially Equivalent	Medtronic Vascular
K791682	CLEON 720 LARGE FIELD GAMMA CAMERA	Dec 13, 1979	Substantially Equivalent	Union Carbide Corp.
K790466	U-MAT	Mar 28, 1979	Substantially Equivalent	Engineering Dynamics Corp.
K790499	MULTIPLE PINHOLE TOMOGRAPHIC COLLIMOTER	Mar 26, 1979	Substantially Equivalent	Engineering Dynamics Corp.
K790463	MODU-SET COLLIMOTOR	Mar 26, 1979	Substantially Equivalent	Medtronic Vascular
K790081	CAMERA, CLEON 720 LARGE FIELD GAMMA	Jan 26, 1979	Substantially Equivalent	Union Carbide Corp.
K782029	MAXI CAMERA 400T	Dec 22, 1978	Substantially Equivalent	General Electric Co.
K782047	PROCESSING SYSTEM, A2 IMAGE	Dec 20, 1978	Substantially Equivalent	Medtronic Vascular
K781739	CAMERA, GCA-10A, LOW ENERGY	Nov 27, 1978	Substantially Equivalent	Toshiba Medical Systems
K781673	MAXI-CAMERA 535	Oct 17, 1978	Substantially Equivalent	General Electric Co.
K780969	GAMMA CAMERA	Jun 27, 1978	Substantially Equivalent	Machlett Laboratories, Inc.
K780971	CLINICAL ACQUISITION MODULE	Jun 22, 1978	Substantially Equivalent	Analytical Development Assoc. Corp.
K780855	GAMMA CAMERA	Jun 02, 1978	Substantially Equivalent	G.D. Searle and Co.
K780491	DATA CAMERA	Apr 18, 1978	Substantially Equivalent	General Electric Co.
K780165	PROCESSOR, VIDEO IMAGE VIP-550	Mar 02, 1978	Substantially Equivalent	Ohio Nuclear, Inc.
K780155	DUAL CHANNEL PULSE HEIGHT ANALYZER	Mar 02, 1978	Substantially Equivalent	Iso Graphics, Inc.
K780060	CAMERA, GAMMA	Jan 26, 1978	Substantially Equivalent	Ackerman-Schmehl Industries, Inc.
K771599	GAMMA CAMERAS -GXA-301 & GCA-402	Sep 20, 1977	Substantially Equivalent	Toshiba Medical Systems
K770954	UNIVUE I	Jul 01, 1977	Substantially Equivalent	Union Carbide Corp.
K770753	PORTA CAMERA IIC	May 10, 1977	Substantially Equivalent	General Electric Co.
K770531	UNICAM I	Apr 05, 1977	Substantially Equivalent	Union Carbide Corp.
K770343	MAXICAMERA II	Feb 28, 1977	Substantially Equivalent	General Electric Co.
K761159	PORTACAMERA 11-B	Dec 06, 1976	Substantially Equivalent	General Electric Co.