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JAK

822 FDA 510(k) clearances · Product code

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RecordFirmDate
CT PERFUSION OPTION (K993791)Ge Medical Systems, Inc.1999-11-24
SMART VESSEL ANALYSIS (SMART VA) OPTION (K993792)Ge Medical Systems, Inc.1999-11-24
EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS (K992740)Imatron, Inc.1999-11-09
SOMATOM PROJECT 10-CT SCANNERS (K991764)Siemens Medical Solutions USA, Inc.1999-08-17
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A (K991766)Toshiba America Medical Systems, In.C1999-08-10
HISPEED NX/I CT SCANNER SYSTEM (K991716)Ge Medical Systems, Inc.1999-06-18
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION (K991600)Siemens Corp.1999-06-09
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION (K991553)Shimadzu Corp.1999-06-08
PHILIPS TOMOSCAN AV-NT (K991278)Philips Medical Systems North America, Inc.1999-05-13
CALCIUM SCORING (K990426)Siemens Medical Solutions USA, Inc.1999-05-12
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION (K984156)Shimadzu Medical Systems1999-04-21
MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) (K990134)Toshiba America Medical Systems, In.C1999-03-19
3D-ANGIO (K984634)Siemens Medical Corp.1999-03-12
PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE (K982536)Siemens Corp.1998-11-24
FACTS (K982010)Philips Medical Systems (Cleveland), Inc.1998-11-19
CT BIOPSYVIEW (K983140)Philips Medical Systems North America, Inc.1998-11-04
ASTEION CT SCANNER, TSX-021A (K982787)Toshiba America Medical Systems, In.C1998-10-21
PHILIPS TOMOSCAN CS (K982631)Philips Medical Systems, Inc.1998-10-06
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL (K982583)Shimadzu Corp.1998-10-05
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS (K982349)Siemens Medical Solutions USA, Inc.1998-09-30
VOLUMAX CT IMAGING SYSTEM (K982060)Elscint, Inc.1998-09-02
AQUILION CT SCANNER, MODEL TSX-101A (K982265)Toshiba America Medical Systems, In.C1998-08-26
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS (K982004)General Electric Co.1998-08-18
ADVANTAGE 3D XR (K974715)GE Medical Systems1998-07-06
CT SCOPE (K974344)Elscint, Inc.1998-06-03
PINPOINT (K974513)Philips Medical Systems (Cleveland), Inc.1998-05-20
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS (K980837)Shimadzu Medical Systems1998-05-20
HISPEED QX/I CT SCANNER SYSTEM (K980176)General Electric Co.1998-04-13
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS (K980169)General Electric Co.1998-04-13
ANATOM 1000 (A MINUS, A-) (K974455)Analogic Corp.1998-02-20
RTR-2000/RTR-4000 (K974307)Terarecon,Inc.1998-02-13
AUKLET CT SCANNER, TSX-003A (K973908)Toshiba America Medical Systems, In.C1997-12-22
SMARTVIEW OPTIONS FOR HISPEED CT/I (K973168)GE Medical Systems1997-11-21
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS (K972903)Imatron, Inc.1997-11-04
ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION (K972879)Imatron, Inc.1997-10-15
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX (K973329)Shimadzu Medical Systems1997-10-08
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH (K973327)Shimadzu Medical Systems1997-10-08
ADVANTAGE WINDOWS VOLUME RENDERING OPTION (K972399)Ge Medical Systems, Inc.1997-09-23
FLY THROUGH (K971717)Siemens Medical Solutions USA, Inc.1997-09-03
TARGOBEAM (K970819)Ferguson Medical1997-07-14
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS (K971054)Siemens Medical Solutions USA, Inc.1997-06-13
CARDIAC SCORING FOR CT SCANNERS (K970980)Elscint, Inc.1997-05-29
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR (K970999)Sony Medical Systems1997-05-20
COMPUTED TOMOGRAPHY X-RAY SYSTEM (K970606)GE Medical Systems1997-04-04
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER (K965004)Siemens Medical Solutions USA, Inc.1997-03-11
ANATOM 2000 (K964890)Analogic Corp.1997-03-06
SOMATOM PLUS 4 CT SCANNER (K964747)Siemens Medical Solutions USA, Inc.1997-02-10
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION (K964746)GE Medical Systems1997-01-24
XRT-7.0 (K964583)Elscint, Inc.1997-01-17
PHILIPS TOMOSCAN AV EXPANDER UPGRADE (K964318)Philips Medical Systems North America, Inc.1997-01-10
MOBILE CT PROSPEED FAMILY (K963896)GE Medical Systems1996-12-18
SLS-CT (K960985)Bio-Imaging Research, Inc.1996-10-25
SELECT/SP (K961464)Elscint, Inc.1996-07-03
CT PROSPEED CT/I (K961055)GE Medical Systems1996-06-17
VIFS (K955583)Konica Medical Corp.1996-05-14
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A (K950972)Toshiba America Medical Systems, In.C1996-04-15
PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS (K960635)Siemens Medical Solutions USA, Inc.1996-04-03
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX (K955255)Shimadzu Medical Systems1996-02-09
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM (K955268)Philips Medical Systems (Cleveland), Inc.1996-01-30
SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH (K955253)Shimadzu Medical Systems1996-01-26
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC (K955254)Shimadzu Medical Systems1996-01-26
DPX TISSUE QUANTIFICATION OUTPUT (K935454)Lunar Corp.1995-10-19
PHILIPS TOMOSCAN SR 8000 (K954255)Philips Medical Systems North America, Inc.1995-10-07
PQ5000 CT SYSTEM (K943623)Philips Medical Systems (Cleveland), Inc.1995-04-27
HRSW OPTION FOR CT TWIN FLASH (K945512)Elscint, Inc.1995-03-14
CT PROSPEED FAMILY (K944013)GE Medical Systems1995-02-07
ANATOM 2000 (K944131)Analogic Corp.1995-01-25
MEDRAD COUNTERPOISE SYSTEM (K944983)Medrad, Inc.1994-11-29
PHILIPS TOMOSCAN SR5000 (K944326)Philips Medical Systems North America, Inc.1994-10-21
PHILIPS TOMOSCAN SR 4000 (K936272)Philips Medical Systems North America, Inc.1994-10-11
SOMATOM PROJECT 059 (K941546)Siemens Corp.1994-09-20
HISPEED ADVANTAGE II (K940606)GE Medical Systems1994-08-23
TSX-002A (XVISION) CT SCANNER (K941745)Toshiba America Medical Systems, In.C1994-07-29
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW (K932508)Elscint, Inc.1994-07-29
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF (K935487)Shimadzu Corp.1994-07-05
MRX-280 (K942040)Mrx Corp.1994-07-05
VOLUMETRIC RENDERING TECHNIQUE OPTION (K923524)Siemens Medical Solutions USA, Inc.1994-05-17
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION (K924985)Siemens Medical Solutions USA, Inc.1994-04-07
SIMULIX-MC CT EXTENSION (K932848)Oldelft Corp. of America1994-03-22
IMPAX 3000 (K934832)Heraeus Kulzer, Inc.1993-12-14
ULTRA COMPACT VIDEO IMAGER (K930765)International Imaging Electronics1993-09-13
HELICAT (K930090)Elscint, Inc.1993-03-19
PHILIPS TOMOSCAN SR7000 CT SYSTEMS (K924082)Philips Medical Systems, Inc.1993-03-10
ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION (K923077)GE Medical Systems1993-02-02
SIM/PLANT (K924810)Columbia Scientific, Inc.1993-01-15
CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM (K921192)GE Medical Systems1992-10-20
SCAN BAND (K923110)Cook, Inc.1992-09-23
WRIST RESTRAINT FOR GE9800 C.T. TABLES (K923108)Cook, Inc.1992-09-23
HEAD RESTRAINT FOR CT TABLES (K923114)Cook, Inc.1992-09-23
ARM EXTENDER FOR CT TABLES (K923111)Cook, Inc.1992-09-23
ADULT CHIN STRAP FOR CT TABLES (K923109)Cook, Inc.1992-09-23
SCAN BAND (K923106)Cook, Inc.1992-09-11
EXCEL CT TWIN (K915738)Elscint, Inc.1992-07-21
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF (K921432)Shimadzu Medical Systems1992-05-28
SYTEC DENTASCAN (K914305)General Electric Co.1992-02-27
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE (K915623)Shimadzu Medical Systems1992-02-14
CT SYTEC 8000 (K913485)General Electric Co.1992-01-23
C-150 ULTRAFAST CT SCANNER (K913352)Imatron, Inc.1991-11-29
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION (K913996)Siemens Medical Solutions USA, Inc.1991-11-22
GYROVIEW-HR (K913029)Philips Medical Systems, Inc.1991-10-15
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