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JAK

822 FDA 510(k) clearances · Product code

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RecordFirmDate
SYNGO CIRCULATION (K052029)Siemens AG Medical Solutions2005-08-09
TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER (K051833)Toshiba America Medical Systems, In.C2005-07-15
CERETOM, MODEL NL3000 (K051765)Neurologica Corporation2005-07-14
SYNGO BODY PERFUSION-CT (K050867)Siemens AG2005-04-14
TSX-201A AQUILION LB CT SCANNER (K050458)Toshiba America Medical Systems, In.C2005-03-10
SOMATOM EMOTION 16 (K050297)Siemens Medical Solution, Inc. USA2005-03-01
SYNGO INSPACE 4D (K043469)Siemens AG Medical Solutions2005-02-03
SOMATOM RESPIRATORY GATING (K043086)Siemens Medical Solutions USA, Inc.2004-12-23
SOMATOM CARE CONTRAST CT (K043087)Siemens Medical Solutions USA, Inc.2004-12-15
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A (K043111)Toshiba America Medical Systems, In.C2004-11-18
SUPERDIMENSION/BRONCHUS (K042438)Superdimension, Ltd.2004-11-08
SOMATOM SPIRIT (K042328)Siemens Medical Systems, Inc.2004-09-14
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER (K042293)Philips Medical Systems (Cleveland), Inc.2004-09-08
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE (K042229)Siemens Medical Solution, Inc. USA2004-09-01
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX (K040782)Image Analysis, Inc.2004-07-13
VOLUME VIEWER PLUS (K041521)General Electric Medical Systems2004-06-22
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS (K041542)Neusoft Digital Medical Systems Co., Ltd.2004-06-17
CARDIQ ANALYSIS III (K041267)General Electric Medical Systems2004-05-27
HITACHI PRESTO (K040902)Hitachi Medical Systems America, Inc.2004-04-21
CADIMPLANT (K040224)Praxim, Inc.2004-04-06
SOMATOM SENSATION 64 AND SENSATION CARDIAC (K040665)Siemens Medical Solutions USA, Inc.2004-04-02
SOMATOM PROJECT P30L (K040577)Siemens Medical Systems, Inc.2004-03-22
CT-MASS (K033774)Medis Medical Imaging Systems BV2004-03-02
LIGHTSPEED 7.0 CT SCANNER SYSTEM (K040372)Ge Medical Systems, LLC2004-03-01
BRAIN PERFUSION OPTION (K033677)Philips Medical Systems (Cleveland), Inc.2004-02-20
ACQSIM-MULTISLICE-CT, MODEL 453567042271 (K033357)Philips Medical Systems (Cleveland), Inc.2004-01-09
SYNGO PERFUSION-CT (K033832)Siemens AG Medical Solutions2003-12-23
LIGHTSPEED 6.0 CT SCANNER SYSTEM (K033502)Ge Medical Systems, LLC2003-11-20
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS (K033418)Toshiba America Medical Systems, In.C2003-11-10
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION (K032536)Siemens Medical Solutions USA, Inc.2003-11-10
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION (K032475)Siemens Medical Solutions USA, Inc.2003-11-10
MEDICHEART, MODEL RELEASE 1 (K032823)Medicsight2003-11-10
MEDIC COLON MODEL, RELEASE 1 (K033102)Medicsight2003-11-05
ADVANTAGE 4D OPTION (K032915)Ge Medical Systems, LLC2003-10-30
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM (K033326)Philips Medical Systems, Inc.2003-10-29
MINICAT DENTOCAT (K032243)Xoran Technologies, Inc.2003-10-02
AUTOBONE (K031871)Ge Medical Systems Europe2003-06-20
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 (K031469)Toshiba America Medical Systems, In.C2003-05-22
RADIOMED SOFT TISSUE MARKER (K031206)Radiomed Corp.2003-05-21
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH (K030450)J. Morita USA, Inc.2003-05-06
CARD EP (K031261)GE Medical Systems2003-05-06
CT COLONOGRAPHY (K023943)Ge Medical Systems, Inc.2003-05-06
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM (K030420)GE Medical Systems2003-03-10
VIDAR BONE TRACK SYSTEM SOFTWARE (K024171)Vidar Systems Corp.2003-03-04
PRIMELUNG (K024149)Accuimage Diagnostics Corp.2003-02-21
LUNG NODULE ASSESSMENT AND COMPARISON OPTION (K023785)Philips Medical Systems (Cleveland), Inc.2003-02-10
RADIOMED MARKER (K022326)Radiomed Corporation2003-01-31
SOMATOM EMOTION 6 CT SYSTEMS (K023687)Siemens Medical Systems, Inc.2002-11-22
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B (K023760)Toshiba America Medical Systems, In.C2002-11-22
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW (K023332)GE Medical Systems2002-10-23
E-SPEED EBT SCANNER SYSTEM (K022794)Ge Imatron2002-10-11
SMART BREATH RESPIRATORY COMPENSATION OPTION (K022919)GE Medical Systems2002-09-19
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM (K022239)Praxim2002-08-23
ULTRAGUIDE CTG 2000SA (K022354)Ultraguide , Ltd.2002-08-13
LODOX, MODEL BASELINE (K013999)Lodox Systems (Pty), Ltd.2002-08-06
LUNGCARE CT SOFTWARE PACKAGE (K022013)Siemens Medical Solutions USA, Inc.2002-07-16
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) (K022050)Toshiba America Medical Systems, In.C2002-07-09
HISPEED DUAL (K021491)Ge Medical Systems, Inc.2002-05-22
CT-C3000 SPIRAL CT SCANNER SYSTEM (K020913)Neusoft Digital Medical Systems Co., Ltd.2002-04-03
SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 (K020929)GE Medical Systems2002-04-03
CARD IQ ANALYSIS II (K020796)GE Medical Systems2002-03-26
PRONTO (K014240)Hitachi Medical Systems America, Inc.2002-03-22
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A (K020385)Toshiba America Medical Systems, In.C2002-02-15
VIATRONIC V3D CALCIUM SCORING (K013146)Viatronix, Inc.2001-12-07
LIGHTSPEED 4.0 CT SCANNER SYSTEM (K013561)GE Medical Systems2001-11-08
GEMINI IMAGING SYSTEM (K013521)Adac Laboratories2001-11-07
SOMATOM P30 CT SYSTEMS (K013522)Siemens Medical Systems, Inc.2001-11-07
CARDIQ FUNCTION (K013422)GE Medical Systems2001-10-30
ADVANCED LUNG ANALYSIS-1 (K013381)General Electric Co.2001-10-26
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A (K013214)Toshiba America Medical Systems, In.C2001-10-05
DOSERIGHT (K012238)Philips Medical Systems North America Co.2001-10-01
ACCUIMAGE SMARTGATE UPGRADE (K012106)Accuimage Diagnostics Corp.2001-09-25
MX8000 IDT CT SYSTEM (K012009)Marconi Medical Systems, Inc.2001-09-13
MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM (K012836)GE Medical Systems2001-09-07
HISPEED X/I SMART GANTRY OPTION (K012385)Ge Medical Systems, Inc.2001-08-10
CT COLONOGRAPHY/NAVIGATOR2 (K012313)Ge Medical Systems, Inc.2001-08-07
IN SPACE 3D (K011447)Siemens Medical Solutions USA, Inc.2001-08-03
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC (K011141)Shimadzu Corp.2001-07-03
CT/MASTER, VERSION 1.0 (K011180)Columbia Scientific, Inc.2001-06-27
MX8000 V5.0 CT SYSTEM (K010817)Philips Medical Systems (Cleveland), Inc.2001-06-15
E-Z EM PERCUPUMP 2001 CT INJECTOR (K011160)E-Z-Em, Inc.2001-05-16
SIMPLICT (K010813)Neorad AS2001-05-07
GE CT-PET SYSTEM (K010641)Ge Medical Systems, Inc.2001-03-30
CT PERFUSION 2 (K010042)General Electric Co.2001-01-30
VITREA 2 CT PERFUSION OPTION (K003639)Vital Images, Inc.2001-01-23
MRI LINE MARKER (K003736)I.Z.I. Corp.2001-01-18
V SCORE WITH AUTO GATE MODEL TBD (K003230)Vital Images, Inc.2000-12-27
CT CORD IQ OPTION 1.0 (K003408)GE Medical Systems2000-11-17
SOMATOM SMILE (K003152)Siemens Medical Solutions USA, Inc.2000-10-24
SOMATOM EMOTION MS (K003014)Siemens Medical Solutions USA, Inc.2000-10-12
LIGTHSPEED 3.0 CT SCANNER SYSTEM (K002978)GE Medical Systems2000-10-10
BOLUSPRO ULTRA (K002005)Marconi Medical Systems, Inc.2000-09-22
ULTRAGUIDE CT-GUIDE 1010 (K002258)Ultraguide , Ltd.2000-08-08
VSCORE WITH EKG SIGNAL GATING (K001682)Vital Images, Inc.2000-06-30
ULTRASIM CT SYSTEM (K001088)Philips Medical Systems (Cleveland), Inc.2000-06-22
PHILIPS CT SECURA MV (K000819)Philips Medical Systems North America, Inc.2000-05-12
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES (K994431)Shimadzu Medical Systems2000-03-23
EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO (K000359)Imatron, Inc.2000-03-17
LIGHTSPEED 2.0CT SCANNER SYSTEM (K000300)Ge Medical Systems, Inc.2000-02-15
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM (K993645)Ge Medical Systems, Inc.1999-12-21
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