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Camera, Scintillation (Gamma)

FDA product code IYX · 129 cleared devices

Class 1 Radiology

Regulation: 21 CFR 892.1100
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-06 – 2023-08-28

IYX 2023-08-28

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)

Applicant Versant Medical Physics and Radiation Safety

K number K230221

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IYX 2023-02-22

3D-RD-S

Applicant Radiopharmaceutical Imaging and Dosimetry, LLC

K number K212587

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IYX 2017-07-19

OLINDA EXM

Applicant Hermes Medical Solutions AB

K number K163687

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IYX 2016-11-18

Discovery NM 750b Bopsy

Applicant GE Healthcare

K number K160933

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IYX 2016-08-18

Sentinella 102, Sentinella 102 Horus

Applicant General Equipment For Medical Imaging (Oncovision-

K number K162052

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IYX 2013-01-15

ERGO IMAGING SYSTEM

Applicant Digirad Corp.

K number K123408

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IYX 2011-09-23

LUMAGEM MOLECULAR BREAST IMAGING SYSTEM

Applicant Gamma Medica-Ideas Incorporated

K number K111791

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IYX 2011-05-03

DILON 6800 ACELLA (ACELLA)

Applicant Dilon Technologies, Inc.

K number K110384

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IYX 2011-03-18

SENTINELLA 102

Applicant General Equipment For Medical Imaging, S.A.

K number K110601

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IYX 2010-11-03

DISCOVERY NM 750B

Applicant Ge Medical Systems Israel, Functional Imaging

K number K102231

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IYX 2010-08-04

SCANDIA-45 GAMMA CAMERA SYSTEM

Applicant Scandia Corporation

K number K101391

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IYX 2010-04-23

ERGO IMAGING SYSTEM

Applicant Digirad Corp.

K number K100838

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IYX 2010-04-02

PROXISCAN MODEL 101

Applicant Hybridyne Imaging Technologies, Inc.

K number K093706

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IYX 2009-12-11

GAMMALOC SYSTEM, MODEL 03-00001

Applicant Dilon Technologies, LLC

K number K082588

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IYX 2009-10-02

MODEL SENTINELLA 102

Applicant General Equipment For Medical Imaging, S.A.

K number K092471

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IYX 2008-08-15

VERISTA IMAGING ISOCAM II GAMMA CAMERA

Applicant Verista Imaging, Inc.

K number K081757

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IYX 2008-07-11

CAPIMAGE

Applicant Danish Diagnostic Development A/S

K number K081829

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IYX 2007-12-20

T-QUEST SYSTEM

Applicant Medx, Inc.

K number K073456

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IYX 2007-06-20

KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5

Applicant Ani-Kal Ii, LLC

K number K071195

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IYX 2006-09-13

MAMMOPAD RADIOLUCENT CUSHION

Applicant Biolucent, Inc.

K number K062141

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IYX 2005-10-28

CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000

Applicant Inter Medical Medizintechnik GmbH

K number K052473

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IYX 2005-06-13

ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM

Applicant Gvi Technology Partners

K number K051402

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IYX 2004-06-15

OLINDA/EXM

Applicant Vanderbilt University

K number K033960

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IYX 2004-05-14

MINI GAMMA CAMERA, MODEL MGC-500

Applicant Acrorad Co., Ltd.

K number K040587

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IYX 2003-01-03

ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101

Applicant Gvi Technology Partners

K number K023373

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IYX 2002-10-09

EZ-SCOPE AN, EZ-SCOPE LIGHT

Applicant Anzai Medical Co., Ltd.

K number K022342

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IYX 2002-05-28

EZ-SCOPE AN & EZ-SCOPE AN LITE

Applicant Health Policy Resorters Group, LLC

K number K020643

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IYX 2001-01-12

PORTABLE BREAST COMPRESSION DEVICE

Applicant Pem Technologies

K number K003775

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IYX 2000-01-18

LUMAGEM SCINTILLATION CAMERA

Applicant Gamma Medica

K number K993813

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IYX 1999-03-16

DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5

Applicant Dilon Technologies, Inc.

K number K984466

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IYX 1997-05-28

NOTEBOOK IMAGER

Applicant Digirad Corp.

K number K961104

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IYX 1995-05-24

IM512P

Applicant Globus Industries

K number K945792

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IYX 1995-05-12

DI-2000

Applicant Miles Inc., Agfa Division

K number K943602

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IYX 1994-04-18

VISION FX 40 & 80 SERIES GAMMA CAMERA

Applicant Summit Nuclear

K number K935273

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IYX 1994-03-29

CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS

Applicant Nuccardiac Software, Inc.

K number K932701

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IYX 1994-02-18

CARBON FIBER PALLET

Applicant Siemens Gammasonics, Inc.

K number K934766

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IYX 1994-02-18

APEX SPX CARDIAL

Applicant Elscint, Inc.

K number K932673

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IYX 1993-11-24

R &D BATTERIES, INC. PART # 5015, 5192, 5482

Applicant R & D Batteries, Inc.

K number K933513

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IYX 1993-10-29

FAN BEAM COLLIMATOR

Applicant Siemens Gammasonics, Inc.

K number K933256

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IYX 1993-08-05

QUANTEM (TM)

Applicant GE Medical Systems

K number K932957

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IYX 1993-07-26

SPECTURN, MODEL TTK-128

Applicant Harpell Assoc., Inc.

K number K923180

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IYX 1993-06-21

THYRUS

Applicant Adac Laboratories

K number K930283

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IYX 1993-03-18

UNIX-LINK

Applicant General Electric Co.

K number K926550

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IYX 1993-02-12

NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES

Applicant Biodan Medical Systems, Ltd.

K number K926083

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IYX 1993-01-15

NEW DETECTOR OPTION

Applicant Adac Laboratories

K number K924878

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IYX 1993-01-15

NEW DETECTOR FOR TRANSCAM/POLARIS S315

Applicant Adac Laboratories

K number K924639

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IYX 1992-09-21

MEDX ROTATIONAL GANTRY SYSTEM

Applicant Bfi- Medical Waste Systems

K number K923356

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IYX 1992-05-28

ADAC S315

Applicant Adac Laboratories

K number K921296

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IYX 1991-07-03

NEUROCAM

Applicant GE Medical Systems

K number K910967

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IYX 1991-06-21

MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM

Applicant Siemens Gammasonics, Inc.

K number K905074

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IYX 1991-04-18

SOPHYCAMERA DSX BODYTRAK

Applicant Sopha Medical Systems, Inc.

K number K911346

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IYX 1991-03-25

ES/ULTRA DISPLAY AND PROCESSING STATION

Applicant Toshiba America Medical Systems, In.C

K number K905412

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IYX 1991-02-04

GAMMA 600 NUCLEAR MEDICINE COMPUTER

Applicant Strichman Medical Equipment, Inc.

K number K903469

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IYX 1991-01-28

FULL VIEW OMEGA TABLE

Applicant Med-Tron Products, Inc.

K number K905827

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IYX 1991-01-04

STARCAM 4000

Applicant General Electric Co.

K number K904174

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IYX 1990-12-05

MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA

Applicant Philips Medical Systems (Cleveland), Inc.

K number K904050

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IYX 1990-10-29

SOPHYCAMERA DSM 315

Applicant Provino

K number K903030

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IYX 1990-10-23

PANORAMIC OMEGA IMAGING TABLE

Applicant Med-Tron Products, Inc.

K number K903988

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IYX 1990-05-23

NUCLEAR MAX

Applicant Scientific Imaging, Inc.

K number K900773

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IYX 1990-04-19

MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA

Applicant Adac Laboratories

K number K900689

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IYX 1989-10-27

SOPHYCAMERA DSX RECTANGULAR

Applicant Sopha Medical Systems, Inc.

K number K894931

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IYX 1989-08-11

XENOS MOBILECAM

Applicant Xenos Medical Systems, Inc.

K number K893379

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IYX 1989-04-19

SYSTEM SEVENTY SEVEN

Applicant Scinticor, Inc.

K number K885054

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IYX 1989-04-17

APEX 609R ANGER CAMERA

Applicant Elscint, Inc.

K number K884675

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IYX 1989-04-17

APEX 415 ANGER CAMERA

Applicant Elscint, Inc.

K number K884674

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IYX 1989-04-17

APEX 115 NUCLEAR MEDICINE PROCESSOR

Applicant Elscint, Inc.

K number K884672

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IYX 1989-04-14

APEX 215M MOBILE ANGER CAMERA

Applicant Elscint, Inc.

K number K884673

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IYX 1989-04-12

D-SCOPE III

Applicant Medx, Inc.

K number K884661

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IYX 1989-03-30

MICRODELTA II

Applicant Siemens Gammasonics, Inc.

K number K885242

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IYX 1988-09-01

CX250 MOBILE GAMMA CAMERA & DCS CONSOLE

Applicant Philips Medical Systems (Cleveland), Inc.

K number K880878

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IYX 1988-08-29

MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A

Applicant Toshiba Medical Systems

K number K881013

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IYX 1988-07-14

MODEL 3000 NUCLEAR CAMERA

Applicant Ohio Imaging, Inc.

K number K882312

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IYX 1988-07-01

DIGITAL NUCLEAR IMAGING SYSTEM

Applicant Medasys, Inc.

K number K875198

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IYX 1987-08-12

DS-7 NUCLEAR MEDICINE GAMMA CAMERA

Applicant Sopha Medical Systems, Inc.

K number K872297

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IYX 1987-06-18

D-SCOPE II AND D-SCOPE IIC

Applicant Medx, Inc.

K number K872127

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IYX 1987-03-31

JUMBO DIGITAL GAMMACAMERA, GCA-901A

Applicant Toshiba Medical Systems

K number K871175

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IYX 1987-03-16

BODYSCAN

Applicant Siemens Gammasonics, Inc.

K number K870818

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IYX 1987-02-26

SKAN D-SCOPE

Applicant Medx, Inc.

K number K870703

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IYX 1986-06-10

WEIGHTED ACQUISITION MODULE

Applicant Siemens Gammasonics, Inc.

K number K861637

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IYX 1986-01-30

STARPORT MODEL H3300AA

Applicant General Electric Co.

K number K852648

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IYX 1986-01-01

ACE COMPUTER SYSTEM

Applicant Cardiac Medical Systems Corp.

K number K853482

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IYX 1985-11-19

JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2

Applicant Toshiba Medical Systems

K number K853470

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IYX 1985-07-18

SATURN NUCLEAR MEDICINE COMPUTER SYSTEM

Applicant Technicare Corp.

K number K852089

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IYX 1985-05-21

SPECTRUM 150 DT

Applicant Raytheon Medical Systems

K number K851644

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IYX 1985-04-10

BASICAM COUNTER BALANCE CAMERA

Applicant Siemens Gammasonics, Inc.

K number K850463

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IYX 1985-03-26

ORBITOR II COUNTER BALANCE CAMERA

Applicant Siemens Gammasonics, Inc.

K number K850397

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IYX 1985-03-01

TOMOGRAPHIC GANTRY

Applicant General Electric Co.

K number K844218

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IYX 1984-12-17

NUCLEAR 700 MEDICINE MECHANICAL POSIT-

Applicant Technicare Corp.

K number K843716

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IYX 1984-11-13

DELTANODE, MEGA DELTA, DELTA LINK-

Applicant Computer Design & Applications, Inc.

K number K843558

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IYX 1984-11-08

KETRONIC MEDAX - N

Applicant Ketronic, Inc.

K number K843288

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IYX 1984-08-21

MICRO DELTA & CELTAPRO

Applicant Computer Design & Applications, Inc.

K number K841964

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IYX 1984-07-06

MAXICAMERA 400 AC

Applicant General Electric Co.

K number K841906

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IYX 1984-03-22

DIGITAL PROCESSING SYSTEM

Applicant Adac Laboratories

K number K840052

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IYX 1984-01-13

INTERAD 520

Applicant Interad Systems, Inc.

K number K833821

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IYX 1983-12-27

CARDIAC CAMERA

Applicant Siemens Gammasonics, Inc.

K number K833811

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IYX 1983-09-12

IMAGE PROCESSING SYS A3

Applicant Metronic, Inc.

K number K832505

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IYX 1982-03-02

ADD'L TERMINAL SUPPORT FOR STAR BASIC

Applicant General Electric Co.

K number K820244

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IYX 1981-12-08

OMEGA 500 RECTANGULAR FIELD CAMERA W/SC

Applicant Technicare Corp.

K number K813073

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IYX 1981-09-08

DYNA- MO

Applicant Philips Medical Systems (Cleveland), Inc.

K number K811629

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IYX 1981-07-20

ROTA CAMERA

Applicant Siemens Gammasonics, Inc.

K number K811715

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