FDA Product Code
FDA Product Code IYX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1100
510(k) Clearances — 130 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) | Versant Medical Physics and Radiation Safety | 2023-08-28 | Traditional | PDF ↗ |
| K212587 | 3D-RD-S | Radiopharmaceutical Imaging and Dosimetry, LLC | 2023-02-22 | Traditional | PDF ↗ |
| K163687 | OLINDA EXM | Hermes Medical Solutions AB | 2017-07-19 | Traditional | PDF ↗ |
| K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016-11-18 | Traditional | PDF ↗ |
| K162052 | Sentinella 102, Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2016-08-18 | Special | PDF ↗ |
| K143156 | Sentinella 102; Sentinella 102 Horus | General Equipment For Medical Imaging (Oncovision- | 2014-11-18 | Traditional | PDF ↗ |
| K123408 | ERGO IMAGING SYSTEM | Digirad Corp. | 2013-01-15 | Traditional | PDF ↗ |
| K111791 | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM | Gamma Medica-Ideas Incorporated | 2011-09-23 | Traditional | PDF ↗ |
| K110384 | DILON 6800 ACELLA (ACELLA) | Dilon Technologies, Inc. | 2011-05-03 | Traditional | PDF ↗ |
| K110601 | SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | 2011-03-18 | Traditional | PDF ↗ |
| K102231 | DISCOVERY NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010-11-03 | Traditional | PDF ↗ |
| K101391 | SCANDIA-45 GAMMA CAMERA SYSTEM | Scandia Corporation | 2010-08-04 | Traditional | PDF ↗ |
| K100838 | ERGO IMAGING SYSTEM | Digirad Corp. | 2010-04-23 | Special | PDF ↗ |
| K093706 | PROXISCAN MODEL 101 | Hybridyne Imaging Technologies, Inc. | 2010-04-02 | Traditional | PDF ↗ |
| K082588 | GAMMALOC SYSTEM, MODEL 03-00001 | Dilon Technologies, LLC | 2009-12-11 | Traditional | PDF ↗ |
| K092471 | MODEL SENTINELLA 102 | General Equipment For Medical Imaging, S.A. | 2009-10-02 | Traditional | PDF ↗ |
| K081757 | VERISTA IMAGING ISOCAM II GAMMA CAMERA | Verista Imaging, Inc. | 2008-08-15 | Special | PDF ↗ |
| K081829 | CAPIMAGE | Danish Diagnostic Development A/S | 2008-07-11 | Traditional | PDF ↗ |
| K073456 | T-QUEST SYSTEM | Medx, Inc. | 2007-12-20 | Traditional | PDF ↗ |
| K071195 | KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 | Ani-Kal Ii, LLC | 2007-06-20 | Traditional | PDF ↗ |
| K062141 | MAMMOPAD RADIOLUCENT CUSHION | Biolucent, Inc. | 2006-09-13 | Traditional | PDF ↗ |
| K052473 | CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 | Inter Medical Medizintechnik GmbH | 2005-10-28 | Traditional | PDF ↗ |
| K051402 | ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM | Gvi Technology Partners | 2005-06-13 | Special | PDF ↗ |
| K033960 | OLINDA/EXM | Vanderbilt University | 2004-06-15 | Traditional | PDF ↗ |
| K040587 | MINI GAMMA CAMERA, MODEL MGC-500 | Acrorad Co., Ltd. | 2004-05-14 | Traditional | PDF ↗ |
| K023373 | ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 | Gvi Technology Partners | 2003-01-03 | Traditional | PDF ↗ |
| K022342 | EZ-SCOPE AN, EZ-SCOPE LIGHT | Anzai Medical Co., Ltd. | 2002-10-09 | Traditional | PDF ↗ |
| K020643 | EZ-SCOPE AN & EZ-SCOPE AN LITE | Health Policy Resorters Group, LLC | 2002-05-28 | Traditional | PDF ↗ |
| K003775 | PORTABLE BREAST COMPRESSION DEVICE | Pem Technologies | 2001-01-12 | Traditional | PDF ↗ |
| K993813 | LUMAGEM SCINTILLATION CAMERA | Gamma Medica | 2000-01-18 | Traditional | PDF ↗ |
| K984466 | DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 | Dilon Technologies, Inc. | 1999-03-16 | Traditional | PDF ↗ |
| K961104 | NOTEBOOK IMAGER | Digirad Corp. | 1997-05-28 | Traditional | PDF ↗ |
| K945792 | IM512P | Globus Industries | 1995-05-24 | Traditional | PDF ↗ |
| K943602 | DI-2000 | Miles Inc., Agfa Division | 1995-05-12 | Traditional | PDF ↗ |
| K935273 | VISION FX 40 & 80 SERIES GAMMA CAMERA | Summit Nuclear | 1994-04-18 | Traditional | PDF ↗ |
| K932701 | CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS | Nuccardiac Software, Inc. | 1994-03-29 | Traditional | PDF ↗ |
| K932673 | APEX SPX CARDIAL | Elscint, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K934766 | CARBON FIBER PALLET | Siemens Gammasonics, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K933513 | R &D BATTERIES, INC. PART # 5015, 5192, 5482 | R & D Batteries, Inc. | 1993-11-24 | Traditional | PDF ↗ |
| K933256 | FAN BEAM COLLIMATOR | Siemens Gammasonics, Inc. | 1993-10-29 | Traditional | PDF ↗ |
| K932957 | QUANTEM (TM) | GE Medical Systems | 1993-08-05 | Traditional | PDF ↗ |
| K923180 | SPECTURN, MODEL TTK-128 | Harpell Assoc., Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K930283 | THYRUS | Adac Laboratories | 1993-06-21 | Traditional | PDF ↗ |
| K926550 | UNIX-LINK | General Electric Co. | 1993-03-18 | Traditional | PDF ↗ |
| K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES | Biodan Medical Systems, Ltd. | 1993-02-12 | Traditional | PDF ↗ |
| K924639 | NEW DETECTOR FOR TRANSCAM/POLARIS S315 | Adac Laboratories | 1993-01-15 | Traditional | PDF ↗ |
| K924878 | NEW DETECTOR OPTION | Adac Laboratories | 1993-01-15 | Traditional | PDF ↗ |
| K923356 | MEDX ROTATIONAL GANTRY SYSTEM | Bfi- Medical Waste Systems | 1992-09-21 | Traditional | PDF ↗ |
| K921296 | ADAC S315 | Adac Laboratories | 1992-05-28 | Traditional | PDF ↗ |
| K910967 | NEUROCAM | GE Medical Systems | 1991-07-03 | Traditional | PDF ↗ |
| K905074 | MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM | Siemens Gammasonics, Inc. | 1991-06-21 | Traditional | PDF ↗ |
| K911346 | SOPHYCAMERA DSX BODYTRAK | Sopha Medical Systems, Inc. | 1991-04-18 | Traditional | PDF ↗ |
| K905412 | ES/ULTRA DISPLAY AND PROCESSING STATION | Toshiba America Medical Systems, In.C | 1991-03-25 | Traditional | PDF ↗ |
| K903469 | GAMMA 600 NUCLEAR MEDICINE COMPUTER | Strichman Medical Equipment, Inc. | 1991-02-04 | Traditional | PDF ↗ |
| K905827 | FULL VIEW OMEGA TABLE | Med-Tron Products, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K904174 | STARCAM 4000 | General Electric Co. | 1991-01-04 | Traditional | PDF ↗ |
| K904050 | MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA | Philips Medical Systems (Cleveland), Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K903030 | SOPHYCAMERA DSM 315 | Provino | 1990-10-29 | Traditional | PDF ↗ |
| K903988 | PANORAMIC OMEGA IMAGING TABLE | Med-Tron Products, Inc. | 1990-10-23 | Traditional | PDF ↗ |
| K900773 | NUCLEAR MAX | Scientific Imaging, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K900689 | MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA | Adac Laboratories | 1990-04-19 | Traditional | PDF ↗ |
| K894931 | SOPHYCAMERA DSX RECTANGULAR | Sopha Medical Systems, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K893379 | XENOS MOBILECAM | Xenos Medical Systems, Inc. | 1989-08-11 | Traditional | PDF ↗ |
| K885054 | SYSTEM SEVENTY SEVEN | Scinticor, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K884672 | APEX 115 NUCLEAR MEDICINE PROCESSOR | Elscint, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K884675 | APEX 609R ANGER CAMERA | Elscint, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K884674 | APEX 415 ANGER CAMERA | Elscint, Inc. | 1989-04-17 | Traditional | PDF ↗ |
| K884673 | APEX 215M MOBILE ANGER CAMERA | Elscint, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K884661 | D-SCOPE III | Medx, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K885242 | MICRODELTA II | Siemens Gammasonics, Inc. | 1989-03-30 | Traditional | PDF ↗ |
| K880878 | CX250 MOBILE GAMMA CAMERA & DCS CONSOLE | Philips Medical Systems (Cleveland), Inc. | 1988-09-01 | Traditional | PDF ↗ |
| K881013 | MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A | Toshiba Medical Systems | 1988-08-29 | Traditional | PDF ↗ |
| K882312 | MODEL 3000 NUCLEAR CAMERA | Ohio Imaging, Inc. | 1988-07-14 | Traditional | PDF ↗ |
| K875198 | DIGITAL NUCLEAR IMAGING SYSTEM | Medasys, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K872297 | DS-7 NUCLEAR MEDICINE GAMMA CAMERA | Sopha Medical Systems, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K872127 | D-SCOPE II AND D-SCOPE IIC | Medx, Inc. | 1987-06-18 | Traditional | PDF ↗ |
| K871175 | JUMBO DIGITAL GAMMACAMERA, GCA-901A | Toshiba Medical Systems | 1987-03-31 | Traditional | PDF ↗ |
| K870818 | BODYSCAN | Siemens Gammasonics, Inc. | 1987-03-16 | Traditional | PDF ↗ |
| K870703 | SKAN D-SCOPE | Medx, Inc. | 1987-02-26 | Traditional | PDF ↗ |
| K861637 | WEIGHTED ACQUISITION MODULE | Siemens Gammasonics, Inc. | 1986-06-10 | Traditional | PDF ↗ |
| K852648 | STARPORT MODEL H3300AA | General Electric Co. | 1986-01-30 | Traditional | PDF ↗ |
| K853482 | ACE COMPUTER SYSTEM | Cardiac Medical Systems Corp. | 1986-01-01 | Traditional | PDF ↗ |
| K853470 | JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2 | Toshiba Medical Systems | 1985-11-19 | Traditional | PDF ↗ |
| K852089 | SATURN NUCLEAR MEDICINE COMPUTER SYSTEM | Technicare Corp. | 1985-07-18 | Traditional | PDF ↗ |
| K851644 | SPECTRUM 150 DT | Raytheon Medical Systems | 1985-05-21 | Traditional | PDF ↗ |
| K850463 | BASICAM COUNTER BALANCE CAMERA | Siemens Gammasonics, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K850397 | ORBITOR II COUNTER BALANCE CAMERA | Siemens Gammasonics, Inc. | 1985-03-26 | Traditional | PDF ↗ |
| K844218 | TOMOGRAPHIC GANTRY | General Electric Co. | 1985-03-01 | Traditional | PDF ↗ |
| K843716 | NUCLEAR 700 MEDICINE MECHANICAL POSIT- | Technicare Corp. | 1984-12-17 | Traditional | PDF ↗ |
| K843558 | DELTANODE, MEGA DELTA, DELTA LINK- | Computer Design & Applications, Inc. | 1984-11-13 | Traditional | PDF ↗ |
| K843288 | KETRONIC MEDAX - N | Ketronic, Inc. | 1984-11-08 | Traditional | PDF ↗ |
| K841964 | MICRO DELTA & CELTAPRO | Computer Design & Applications, Inc. | 1984-08-21 | Traditional | PDF ↗ |
| K841906 | MAXICAMERA 400 AC | General Electric Co. | 1984-07-06 | Traditional | PDF ↗ |
| K840052 | DIGITAL PROCESSING SYSTEM | Adac Laboratories | 1984-03-22 | Traditional | PDF ↗ |
| K833821 | INTERAD 520 | Interad Systems, Inc. | 1984-01-13 | Traditional | PDF ↗ |
| K833811 | CARDIAC CAMERA | Siemens Gammasonics, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K832505 | IMAGE PROCESSING SYS A3 | Metronic, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K820244 | ADD'L TERMINAL SUPPORT FOR STAR BASIC | General Electric Co. | 1982-03-02 | Traditional | PDF ↗ |
| K813073 | OMEGA 500 RECTANGULAR FIELD CAMERA W/SC | Technicare Corp. | 1981-12-08 | Traditional | PDF ↗ |
| K811629 | DYNA- MO | Philips Medical Systems (Cleveland), Inc. | 1981-09-08 | Traditional | PDF ↗ |
Product code IYX · Class I · Radiology. Data: openFDA.