FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K040587 |
ACRORAD CO., LTD. |
MINI GAMMA CAMERA, MODEL MGC-500 |
05/14/2004 |
K071195 |
ANI-KAL II, LLC |
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 |
06/20/2007 |
K022342 |
ANZAI MEDICAL CO, LTD. |
EZ-SCOPE AN, EZ-SCOPE LIGHT |
10/09/2002 |
K062141 |
BIOLUCENT, INC. |
MAMMOPAD RADIOLUCENT CUSHION |
09/13/2006 |
K081829 |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
CAPIMAGE |
07/11/2008 |
K100838 |
DIGIRAD CORP. |
ERGO IMAGING SYSTEM |
04/23/2010 |
K123408 |
DIGIRAD CORP. |
ERGO IMAGING SYSTEM |
01/15/2013 |
K961104 |
DIGIRAD CORP. |
NOTEBOOK IMAGER |
05/28/1997 |
K082588 |
DILON TECHNOLOGIES LLC |
GAMMALOC SYSTEM, MODEL 03-00001 |
12/11/2009 |
K984466 |
DILON TECHNOLOGIES, INC. |
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 |
03/16/1999 |
K110384 |
DILON TECHNOLOGIES, INC. |
DILON 6800 ACELLA (ACELLA) |
05/03/2011 |
K993813 |
GAMMA MEDICA |
LUMAGEM SCINTILLATION CAMERA |
01/18/2000 |
K111791 |
GAMMA MEDICA-IDEAS INCORPORATED |
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM |
09/23/2011 |
K160933 |
GE Healthcare |
Discovery NM 750b Bopsy |
11/18/2016 |
K102231 |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
DISCOVERY NM 750B |
11/03/2010 |
K162052 |
GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- |
Sentinella 102, Sentinella 102 Horus |
08/18/2016 |
K143156 |
GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- |
Sentinella 102; Sentinella 102 Horus |
11/18/2014 |
K092471 |
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A |
MODEL SENTINELLA 102 |
10/02/2009 |
K110601 |
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A |
SENTINELLA 102 |
03/18/2011 |
K023373 |
GVI TECHNOLOGY PARTNERS |
ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 |
01/03/2003 |
K051402 |
GVI TECHNOLOGY PARTNERS |
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM |
06/13/2005 |
K020643 |
HEALTH POLICY RESORTERS GROUP, LLC |
EZ-SCOPE AN & EZ-SCOPE AN LITE |
05/28/2002 |
K163687 |
Hermes Medical Solutions AB |
OLINDA EXM |
07/19/2017 |
K093706 |
HYBRIDYNE IMAGING TECHNOLOGIES, INC |
PROXISCAN MODEL 101 |
04/02/2010 |
K052473 |
INTER MEDICAL MEDIZINTECHNIK GMBH |
CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 |
10/28/2005 |
K073456 |
MEDX, INC. |
T-QUEST SYSTEM |
12/20/2007 |
K003775 |
PEM TECHNOLOGIES |
PORTABLE BREAST COMPRESSION DEVICE |
01/12/2001 |
K212587 |
Radiopharmaceutical Imaging and Dosimetry, LLC |
3D-RD-S |
02/22/2023 |
K101391 |
SCANDIA CORPORATION |
SCANDIA-45 GAMMA CAMERA SYSTEM |
08/04/2010 |
K033960 |
VANDERBILT UNIVERSITY |
OLINDA/EXM |
06/15/2004 |
K081757 |
VERISTA IMAGING INC. |
VERISTA IMAGING ISOCAM II GAMMA CAMERA |
08/15/2008 |
K230221 |
Versant Medical Physics and Radiation Safety |
QDOSE« Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) |
08/28/2023 |