Camera, Scintillation (Gamma)
Regulation 892.1100
0510(k)s in 12 months (130 all time)
2recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in IYX
| Company | 510(k)s | Recalls |
|---|---|---|
| General Electric Co. | 15 | 0 |
| Siemens Gammasonics, Inc. | 11 | 0 |
| Adac Laboratories | 6 | 0 |
| Elscint, Inc. | 5 | 0 |
| Medtronic Vascular | 5 | 0 |
| Toshiba Medical Systems | 5 | 0 |
| Medx, Inc. | 4 | 0 |
| Union Carbide Corp. | 4 | 0 |
| Digirad Corp. | 3 | 0 |
| Dilon Technologies, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 28, 2023 | K230221 | QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) Versant Medical Physics and Radiation Safety | IYX |
| Feb 22, 2023 | K212587 | 3D-RD-S Radiopharmaceutical Imaging and Dosimetry, LLC | IYX |
| Jul 19, 2017 | K163687 | OLINDA EXM Hermes Medical Solutions AB, SE | IYX |
| Nov 18, 2016 | K160933 | Discovery NM 750b Bopsy GE Healthcare, IL | IYX |
| Aug 18, 2016 | K162052 | Sentinella 102, Sentinella 102 Horus General Equipment For Medical Imaging (Oncovision-, ES | IYX |
| Nov 18, 2014 | K143156 | Sentinella 102; Sentinella 102 Horus General Equipment For Medical Imaging (Oncovision-, ES | IYX |
| Jan 15, 2013 | K123408 | ERGO IMAGING SYSTEM Digirad Corp. | IYX |
| Sep 23, 2011 | K111791 | LUMAGEM MOLECULAR BREAST IMAGING SYSTEM Gamma Medica-Ideas Incorporated | IYX |
| May 3, 2011 | K110384 | DILON 6800 ACELLA (ACELLA) Dilon Technologies, Inc. | IYX |
| Mar 18, 2011 | K110601 | SENTINELLA 102 General Equipment For Medical Imaging, S.A., ES | IYX |
| Nov 3, 2010 | K102231 | DISCOVERY NM 750B Ge Medical Systems Israel, Functional Imaging, IL | IYX |
| Aug 4, 2010 | K101391 | SCANDIA-45 GAMMA CAMERA SYSTEM Scandia Corporation | IYX |
| Apr 23, 2010 | K100838 | ERGO IMAGING SYSTEM Digirad Corp. | IYX |
| Apr 2, 2010 | K093706 | PROXISCAN MODEL 101 Hybridyne Imaging Technologies, Inc. | IYX |
| Dec 11, 2009 | K082588 | GAMMALOC SYSTEM, MODEL 03-00001 Dilon Technologies, LLC | IYX |
| Oct 2, 2009 | K092471 | MODEL SENTINELLA 102 General Equipment For Medical Imaging, S.A., ES | IYX |
| Aug 15, 2008 | K081757 | VERISTA IMAGING ISOCAM II GAMMA CAMERA Verista Imaging, Inc. | IYX |
| Jul 11, 2008 | K081829 | CAPIMAGE Danish Diagnostic Development A/S, DK | IYX |
| Dec 20, 2007 | K073456 | T-QUEST SYSTEM Medx, Inc. | IYX |
| Jun 20, 2007 | K071195 | KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 Ani-Kal Ii, LLC | IYX |
| Sep 13, 2006 | K062141 | MAMMOPAD RADIOLUCENT CUSHION Biolucent, Inc. | IYX |
| Oct 28, 2005 | K052473 | CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 Inter Medical Medizintechnik GmbH, DE | IYX |
| Jun 13, 2005 | K051402 | ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM Gvi Technology Partners | IYX |
| Jun 15, 2004 | K033960 | OLINDA/EXM Vanderbilt University | IYX |
| May 14, 2004 | K040587 | MINI GAMMA CAMERA, MODEL MGC-500 Acrorad Co., Ltd. | IYX |
| Jan 3, 2003 | K023373 | ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 Gvi Technology Partners | IYX |
| Oct 9, 2002 | K022342 | EZ-SCOPE AN, EZ-SCOPE LIGHT Anzai Medical Co., Ltd. | IYX |
| May 28, 2002 | K020643 | EZ-SCOPE AN & EZ-SCOPE AN LITE Health Policy Resorters Group, LLC | IYX |
| Jan 12, 2001 | K003775 | PORTABLE BREAST COMPRESSION DEVICE Pem Technologies | IYX |
| Jan 18, 2000 | K993813 | LUMAGEM SCINTILLATION CAMERA Gamma Medica | IYX |
| Mar 16, 1999 | K984466 | DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 Dilon Technologies, Inc. | IYX |
| May 28, 1997 | K961104 | NOTEBOOK IMAGER Digirad Corp. | IYX |
| May 24, 1995 | K945792 | IM512P Globus Industries | IYX |
| May 12, 1995 | K943602 | DI-2000 Miles Inc., Agfa Division | IYX |
| Apr 18, 1994 | K935273 | VISION FX 40 & 80 SERIES GAMMA CAMERA Summit Nuclear | IYX |
| Mar 29, 1994 | K932701 | CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS Nuccardiac Software, Inc. | IYX |
| Feb 18, 1994 | K934766 | CARBON FIBER PALLET Siemens Gammasonics, Inc. | IYX |
| Feb 18, 1994 | K932673 | APEX SPX CARDIAL Elscint, Inc. | IYX |
| Nov 24, 1993 | K933513 | R &D BATTERIES, INC. PART # 5015, 5192, 5482 R & D Batteries, Inc. | IYX |
| Oct 29, 1993 | K933256 | FAN BEAM COLLIMATOR Siemens Gammasonics, Inc. | IYX |
| Aug 5, 1993 | K932957 | QUANTEM (TM) GE Medical Systems | IYX |
| Jul 26, 1993 | K923180 | SPECTURN, MODEL TTK-128 Harpell Assoc., Inc., CA | IYX |
| Jun 21, 1993 | K930283 | THYRUS Adac Laboratories | IYX |
| Mar 18, 1993 | K926550 | UNIX-LINK General Electric Co. | IYX |
| Feb 12, 1993 | K926083 | NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES Biodan Medical Systems, Ltd. | IYX |
| Jan 15, 1993 | K924878 | NEW DETECTOR OPTION Adac Laboratories | IYX |
| Jan 15, 1993 | K924639 | NEW DETECTOR FOR TRANSCAM/POLARIS S315 Adac Laboratories | IYX |
| Sep 21, 1992 | K923356 | MEDX ROTATIONAL GANTRY SYSTEM Bfi- Medical Waste Systems | IYX |
| May 28, 1992 | K921296 | ADAC S315 Adac Laboratories, DK | IYX |
| Jul 3, 1991 | K910967 | NEUROCAM GE Medical Systems | IYX |
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