Atlas FDA

IYX

130 FDA 510(k) clearances · Product code

71 daysmedian time to decision
197 days90th percentile
130clearances measured

FDA profile

Official device name
Camera, Scintillation (Gamma)
Device class
Class I (low risk)
Regulation
21 CFR 892.1100
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2006: 12 · 2007: 11 · 2008: 10 · 2009: 8 · 2010: 5 · 2011: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) (K230221)Versant Medical Physics and Radiation Safety2023-08-28
3D-RD-S (K212587)Radiopharmaceutical Imaging and Dosimetry, LLC2023-02-22
OLINDA EXM (K163687)Hermes Medical Solutions AB2017-07-19
Discovery NM 750b Bopsy (K160933)GE Healthcare2016-11-18
Sentinella 102, Sentinella 102 Horus (K162052)General Equipment For Medical Imaging (Oncovision-2016-08-18
Sentinella 102; Sentinella 102 Horus (K143156)General Equipment For Medical Imaging (Oncovision-2014-11-18
ERGO IMAGING SYSTEM (K123408)Digirad Corp.2013-01-15
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM (K111791)Gamma Medica-Ideas Incorporated2011-09-23
DILON 6800 ACELLA (ACELLA) (K110384)Dilon Technologies, Inc.2011-05-03
SENTINELLA 102 (K110601)General Equipment For Medical Imaging, S.A.2011-03-18
DISCOVERY NM 750B (K102231)Ge Medical Systems Israel, Functional Imaging2010-11-03
SCANDIA-45 GAMMA CAMERA SYSTEM (K101391)Scandia Corporation2010-08-04
ERGO IMAGING SYSTEM (K100838)Digirad Corp.2010-04-23
PROXISCAN MODEL 101 (K093706)Hybridyne Imaging Technologies, Inc.2010-04-02
GAMMALOC SYSTEM, MODEL 03-00001 (K082588)Dilon Technologies, LLC2009-12-11
MODEL SENTINELLA 102 (K092471)General Equipment For Medical Imaging, S.A.2009-10-02
VERISTA IMAGING ISOCAM II GAMMA CAMERA (K081757)Verista Imaging, Inc.2008-08-15
CAPIMAGE (K081829)Danish Diagnostic Development A/S2008-07-11
T-QUEST SYSTEM (K073456)Medx, Inc.2007-12-20
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 (K071195)Ani-Kal Ii, LLC2007-06-20
MAMMOPAD RADIOLUCENT CUSHION (K062141)Biolucent, Inc.2006-09-13
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 (K052473)Inter Medical Medizintechnik GmbH2005-10-28
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM (K051402)Gvi Technology Partners2005-06-13
OLINDA/EXM (K033960)Vanderbilt University2004-06-15
MINI GAMMA CAMERA, MODEL MGC-500 (K040587)Acrorad Co., Ltd.2004-05-14
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 (K023373)Gvi Technology Partners2003-01-03
EZ-SCOPE AN, EZ-SCOPE LIGHT (K022342)Anzai Medical Co., Ltd.2002-10-09
EZ-SCOPE AN & EZ-SCOPE AN LITE (K020643)Health Policy Resorters Group, LLC2002-05-28
PORTABLE BREAST COMPRESSION DEVICE (K003775)Pem Technologies2001-01-12
LUMAGEM SCINTILLATION CAMERA (K993813)Gamma Medica2000-01-18
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 (K984466)Dilon Technologies, Inc.1999-03-16
NOTEBOOK IMAGER (K961104)Digirad Corp.1997-05-28
IM512P (K945792)Globus Industries1995-05-24
DI-2000 (K943602)Miles Inc., Agfa Division1995-05-12
VISION FX 40 & 80 SERIES GAMMA CAMERA (K935273)Summit Nuclear1994-04-18
CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS (K932701)Nuccardiac Software, Inc.1994-03-29
APEX SPX CARDIAL (K932673)Elscint, Inc.1994-02-18
CARBON FIBER PALLET (K934766)Siemens Gammasonics, Inc.1994-02-18
R &D BATTERIES, INC. PART # 5015, 5192, 5482 (K933513)R & D Batteries, Inc.1993-11-24
FAN BEAM COLLIMATOR (K933256)Siemens Gammasonics, Inc.1993-10-29
QUANTEM (TM) (K932957)GE Medical Systems1993-08-05
SPECTURN, MODEL TTK-128 (K923180)Harpell Assoc., Inc.1993-07-26
THYRUS (K930283)Adac Laboratories1993-06-21
UNIX-LINK (K926550)General Electric Co.1993-03-18
NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES (K926083)Biodan Medical Systems, Ltd.1993-02-12
NEW DETECTOR OPTION (K924878)Adac Laboratories1993-01-15
NEW DETECTOR FOR TRANSCAM/POLARIS S315 (K924639)Adac Laboratories1993-01-15
MEDX ROTATIONAL GANTRY SYSTEM (K923356)Bfi- Medical Waste Systems1992-09-21
ADAC S315 (K921296)Adac Laboratories1992-05-28
NEUROCAM (K910967)GE Medical Systems1991-07-03
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM (K905074)Siemens Gammasonics, Inc.1991-06-21
SOPHYCAMERA DSX BODYTRAK (K911346)Sopha Medical Systems, Inc.1991-04-18
ES/ULTRA DISPLAY AND PROCESSING STATION (K905412)Toshiba America Medical Systems, In.C1991-03-25
GAMMA 600 NUCLEAR MEDICINE COMPUTER (K903469)Strichman Medical Equipment, Inc.1991-02-04
FULL VIEW OMEGA TABLE (K905827)Med-Tron Products, Inc.1991-01-28
STARCAM 4000 (K904174)General Electric Co.1991-01-04
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA (K904050)Philips Medical Systems (Cleveland), Inc.1990-12-05
SOPHYCAMERA DSM 315 (K903030)Provino1990-10-29
PANORAMIC OMEGA IMAGING TABLE (K903988)Med-Tron Products, Inc.1990-10-23
NUCLEAR MAX (K900773)Scientific Imaging, Inc.1990-05-23
MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA (K900689)Adac Laboratories1990-04-19
SOPHYCAMERA DSX RECTANGULAR (K894931)Sopha Medical Systems, Inc.1989-10-27
XENOS MOBILECAM (K893379)Xenos Medical Systems, Inc.1989-08-11
SYSTEM SEVENTY SEVEN (K885054)Scinticor, Inc.1989-04-19
APEX 609R ANGER CAMERA (K884675)Elscint, Inc.1989-04-17
APEX 415 ANGER CAMERA (K884674)Elscint, Inc.1989-04-17
APEX 115 NUCLEAR MEDICINE PROCESSOR (K884672)Elscint, Inc.1989-04-17
APEX 215M MOBILE ANGER CAMERA (K884673)Elscint, Inc.1989-04-14
D-SCOPE III (K884661)Medx, Inc.1989-04-12
MICRODELTA II (K885242)Siemens Gammasonics, Inc.1989-03-30
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE (K880878)Philips Medical Systems (Cleveland), Inc.1988-09-01
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A (K881013)Toshiba Medical Systems1988-08-29
MODEL 3000 NUCLEAR CAMERA (K882312)Ohio Imaging, Inc.1988-07-14
DIGITAL NUCLEAR IMAGING SYSTEM (K875198)Medasys, Inc.1988-07-01
DS-7 NUCLEAR MEDICINE GAMMA CAMERA (K872297)Sopha Medical Systems, Inc.1987-08-12
D-SCOPE II AND D-SCOPE IIC (K872127)Medx, Inc.1987-06-18
JUMBO DIGITAL GAMMACAMERA, GCA-901A (K871175)Toshiba Medical Systems1987-03-31
BODYSCAN (K870818)Siemens Gammasonics, Inc.1987-03-16
SKAN D-SCOPE (K870703)Medx, Inc.1987-02-26
WEIGHTED ACQUISITION MODULE (K861637)Siemens Gammasonics, Inc.1986-06-10
STARPORT MODEL H3300AA (K852648)General Electric Co.1986-01-30
ACE COMPUTER SYSTEM (K853482)Cardiac Medical Systems Corp.1986-01-01
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 (K853470)Toshiba Medical Systems1985-11-19
SATURN NUCLEAR MEDICINE COMPUTER SYSTEM (K852089)Technicare Corp.1985-07-18
SPECTRUM 150 DT (K851644)Raytheon Medical Systems1985-05-21
BASICAM COUNTER BALANCE CAMERA (K850463)Siemens Gammasonics, Inc.1985-04-10
ORBITOR II COUNTER BALANCE CAMERA (K850397)Siemens Gammasonics, Inc.1985-03-26
TOMOGRAPHIC GANTRY (K844218)General Electric Co.1985-03-01
NUCLEAR 700 MEDICINE MECHANICAL POSIT- (K843716)Technicare Corp.1984-12-17
DELTANODE, MEGA DELTA, DELTA LINK- (K843558)Computer Design & Applications, Inc.1984-11-13
KETRONIC MEDAX - N (K843288)Ketronic, Inc.1984-11-08
MICRO DELTA & CELTAPRO (K841964)Computer Design & Applications, Inc.1984-08-21
MAXICAMERA 400 AC (K841906)General Electric Co.1984-07-06
DIGITAL PROCESSING SYSTEM (K840052)Adac Laboratories1984-03-22
INTERAD 520 (K833821)Interad Systems, Inc.1984-01-13
CARDIAC CAMERA (K833811)Siemens Gammasonics, Inc.1983-12-27
IMAGE PROCESSING SYS A3 (K832505)Metronic, Inc.1983-09-12
ADD'L TERMINAL SUPPORT FOR STAR BASIC (K820244)General Electric Co.1982-03-02
OMEGA 500 RECTANGULAR FIELD CAMERA W/SC (K813073)Technicare Corp.1981-12-08
DYNA- MO (K811629)Philips Medical Systems (Cleveland), Inc.1981-09-08
Next →

Track IYX automatically

Every clearance here is in the API, with alerts when new ones post.