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JAK

822 FDA 510(k) clearances · Product code

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RecordFirmDate
SOMATOM DEFINITION AS (K103127)Siemens Medical Solutions USA, Inc.2011-03-04
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM (K102259)VATECH Co., Ltd.2011-02-18
SUPERDIMENSION MARKER DELIVERY KIT (K110093)Superdimension, Inc.2011-02-11
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 (K093891)Toshibamedical Systems Corporation2010-11-18
I-LOGIC INREACH SYSTEM (K102604)Superdimension, Ltd.2010-10-07
ICAD VERALOOK CTC CAD SOFTWARE (K091529)Icad, Inc.2010-08-04
BF-NAVI (K093810)Kgt, Inc.2010-06-18
SYNGO.CT CORONARY ANALYSIS (K100637)Siemens AG Medical Solutions2010-05-26
IGUIDE CAPPA (K093787)Cas Innovations GmbH & Co. KG2010-03-11
IG 4 IMAGE GUIDED SYSTEM (K093995)Veran Medical Technologies, Inc.2010-01-27
IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 (K091934)Veran Medical Technologies, Inc.2009-12-02
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 (K093146)Veran Medical Technologies, Inc.2009-11-30
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL (K092747)Philips Medical Systems (Cleveland), Inc.2009-10-09
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO (K090991)E-Woo Technology2009-10-09
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K092742)Neusoft Medical Systems Co., Ltd.2009-09-22
INREACH SYSTEM, MODEL AAS00161-02 (K092365)Superdimension, Ltd.2009-09-04
SYNGO VOLUME PERFUSION-CT BODY (K092013)Siemens AG Medical Solutions2009-07-17
GE LIGHTSPEED ACT FP16 (K091673)Ge Medical Systems, Inc.2009-06-24
BRILLIANCE DUAL ENERGY OPTION (K090462)Philips Medical Systems (Cleveland), Inc.2009-06-23
GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS (K091103)Hitachi Medical Systems America, Inc.2009-06-15
PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 (K091195)Philips Medical Systems (Cleveland), Inc.2009-05-27
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY (K083524)Siemens Medical Solutions USA, Inc.2009-04-01
CSBP-001A BODY PERFUSION SYSTEM (K090504)Toshibamedical Systems Corporation2009-03-05
COLON VIEW, MODEL CSCV-001A (K090220)Toshibamedical Systems Corporation2009-02-11
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM (K090173)Neusoft Medical Systems Co., Ltd.2009-02-05
PHILIPS MODEL MX 16 SLICE CT SYSTEM (K083498)Philips Medical Systems (Cleveland), Inc.2008-12-17
MODEL TSX-301B AQUILION CT SYSTEM (K083282)Toshiba America Medical Systems, In.C2008-12-12
VIATRONIX V3D-CARDIAC, REVISION 1.0 (K083293)Viatronix, Inc.2008-12-05
VIDA PULMONARY WORKSTATION 2 (PW2) (K083227)Vida Diagnostics, Inc.2008-11-18
GE XTREME INJECTOR OPTION (K082960)Ge Medical Systems, LLC2008-10-17
P3T ABDOMEN (K082458)Medrad, Inc.2008-10-17
VB IMAGE VIEWER (K080581)Olympus Medical Systems Corporation2008-10-16
SOMATOM FLASH DS (K082220)Siemens Medical Solutions USA, Inc.2008-10-10
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM (K082816)Ge Medical Systems, LLC2008-10-08
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM (K082761)Ge Medical Systems, LLC2008-10-08
GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM (K082104)Ge Medical Systems, Inc.2008-09-02
PICASSO MASTER, ECT AND MASTER 3D (K081847)E-Woo Technology2008-08-21
CSBP-001A BODY ORGAN PERFUSION SYSTEM (K081482)Toshiba America Medical Systems, In.C2008-06-11
MODIFICATION TO INREACH SYSTEM (K081379)Superdimension, Ltd.2008-06-11
SOMATOM DEFINITION, MODEL AS/AS+ (K081022)Siemens Medical Solutions USA, Inc.2008-06-02
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) (K081105)GE Healthcare2008-05-09
NAVSTATIONIRAD EMT, VERSION 1.1 (K080624)Cas Innovations AG2008-04-11
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 (K073695)J. Morita USA, Inc.2008-04-09
INREACH SYSTEM (K080271)Superdimension, Ltd.2008-03-31
ZIEHM VISION 2 (K073346)Ziehm Imaging, Inc.2008-03-21
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM (K080211)Toshiba America Medical Systems, In.C2008-03-14
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 (K080540)Neusoft Medical Systems Co., Ltd.2008-03-13
CARDIQ EXPRESS VERSION 2.0 (K073138)GE Medical Systems2008-02-26
CARDIQ FUNCTION XPRESS (K073153)GE Medical Systems SCS2008-02-26
SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY (K073003)Siemens Medi Cal Solutions, Inc.2008-02-07
SYNGO VOLUME PERFUSION-CT NEURO (K073238)Siemens AG Medical Solutions2008-01-03
SYNGO VOLUME PERFUSION-CT BODY (K073373)Siemens AG Medical Solutions2007-12-18
CSNP-001A NEURO PACKAGE (K072693)Toshiba America Medical Systems, In.C2007-11-01
ALPHARD CONE BEAM CT, MODEL X178 (K072574)Takara Belmont Corp.2007-10-18
NEUVIZ SPIRAL CT SCANNER SYSTEM (K072841)Neusoft Medical Systems Co., Ltd.2007-10-16
CSCS-001A CALCIUM SCORING PACKAGE (K072737)Toshiba America Medical Systems, In.C2007-10-05
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM (K072606)Toshiba America Medical Systems, In.C2007-10-02
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM (K071806)Hitachi Medical Systems America, Inc.2007-08-28
MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K071308)Neusoft Medical Systems Co., Ltd.2007-08-16
INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K071513)Siemens Medical Solutions2007-06-26
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES (K071378)E-Z-Em, Inc.2007-06-13
SYNGO CT ONCOLOGY SOFTWARE PACKAGE (K071310)Siemens AG2007-06-08
DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM (K070658)E-Woo Technology2007-04-05
PET VCAR (K063324)GE Healthcare2007-03-23
SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (K063762)Siemens AG Medical Solutions2007-01-05
SYNGO NEURO PBV CT (K063507)Siemens AG2006-11-30
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION (K063241)Toshiba America Medical Systems, In.C2006-11-09
TSX-301A, AQUILION ONE CT SYSTEM (K063189)Toshiba America Medical Systems, In.C2006-11-03
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION (K063184)Toshiba America Medical Systems, In.C2006-11-03
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 (K063029)E-Z-Em, Inc.2006-11-02
QANGIO CT (K062386)Medis Medical Imaging Systems BV2006-10-05
SYNGO DUAL ENERGY (K062351)Siemens Medical Solutions USA, Inc.2006-10-05
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM (K062451)Neusoft Medical Systems Co., Ltd.2006-09-28
MODIFICATION TO SYNGO INSPACE 4D (K062673)Siemens AG Medical Solutions2006-09-22
SUPERDIMENSION/BRONCHUS PREMIUM 2 (K062315)Superdimension, Ltd.2006-09-08
XCAT; XCAT FOR NEURO (K061834)Xoran Technologies, Inc.2006-08-07
SYNGO EXPERT-1 (K061449)Siemens Medical Solution2006-07-25
LIGHTSPEED 7.1 CT SCANNER SYSTEM (K061817)Ge Medical Systems, LLC2006-07-12
ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM (K061310)Ziehm Imaging, Inc.2006-07-07
AUTOBONE2 (K061625)GE Healthcare2006-06-26
BRILLIANCE VOLUME (K060937)Philips Medical Systems (Cleveland), Inc.2006-06-05
CARDIQ FUSION (K061370)GE Healthcare2006-05-30
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING (K061187)Toshiba America Medical Systems, In.C2006-05-12
IG4 IMAGE GUIDED SYSTEM (K060903)Veran Medical Technologies, Inc.2006-05-11
GE LIGHTSPEED XTRA CT SCANNER SYSTEM (K060052)Ge Medical Systems, LLC2006-04-19
ABARIS (K053610)Traxtal Technologies, Inc.2006-04-19
ADVANCE VESSEL ANALYSIS II (K060779)GE Healthcare2006-04-05
CT PERFUSION 4 (K052839)GE Healthcare2006-03-10
CXR16 (K053148)Hitachi Medical Systems America, Inc.2006-02-17
MAYFIELD SCANMATE MOBILE CT SYSTEM (K053210)Schaerer Mayfield USA, Inc.2006-01-06
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF (K052587)J. Morita USA, Inc.2005-12-27
SUPERDIMENSION/BRONCHUS PREMIUM (K052852)Superdimension, Ltd.2005-11-14
ILUMA ORTHOCAT/DENTALCAT (K053046)Imtec Corp.2005-11-08
SYNGO NEURO DSA CT (K053024)Siemens AG2005-11-04
STARSPEED SERIES CT SCANNER SYSTEMS (K052855)GE Healthcare2005-10-28
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 (K052447)Analogic Corp.2005-09-21
SOMATOM DEFINITION (K052216)Siemens Medical Systems, Inc.2005-09-08
SUPERDIMENSION/BRONCHUS 4.1 (K052260)Superdimension, Ltd.2005-09-08
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ (K052157)Ge Medical Systems, LLC2005-08-25
DVT SCANNER (K051980)Imaging Sciences Intl., Inc.2005-08-19
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