System, X-Ray, Tomography, Computed
Regulation 892.1750
22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
Top companies in JAK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2003 | K023785 | LUNG NODULE ASSESSMENT AND COMPARISON OPTION Philips Medical Systems (Cleveland), Inc. | JAK |
| Jan 31, 2003 | K022326 | RADIOMED MARKER Radiomed Corporation | JAK |
| Nov 22, 2002 | K023760 | CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B Toshiba America Medical Systems, In.C | JAK |
| Nov 22, 2002 | K023687 | SOMATOM EMOTION 6 CT SYSTEMS Siemens Medical Systems, Inc. | JAK |
| Oct 23, 2002 | K023332 | LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW GE Medical Systems | JAK |
| Oct 11, 2002 | K022794 | E-SPEED EBT SCANNER SYSTEM Ge Imatron | JAK |
| Sep 19, 2002 | K022919 | SMART BREATH RESPIRATORY COMPENSATION OPTION GE Medical Systems | JAK |
| Aug 23, 2002 | K022239 | SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM Praxim | JAK |
| Aug 13, 2002 | K022354 | ULTRAGUIDE CTG 2000SA Ultraguide , Ltd. | JAK |
| Aug 6, 2002 | K013999 | LODOX, MODEL BASELINE Lodox Systems (Pty), Ltd. | JAK |
| Jul 16, 2002 | K022013 | LUNGCARE CT SOFTWARE PACKAGE Siemens Medical Solutions USA, Inc. | JAK |
| Jul 9, 2002 | K022050 | CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) Toshiba America Medical Systems, In.C | JAK |
| May 22, 2002 | K021491 | HISPEED DUAL Ge Medical Systems, Inc. | JAK |
| Apr 3, 2002 | K020929 | SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 GE Medical Systems, FR | JAK |
| Apr 3, 2002 | K020913 | CT-C3000 SPIRAL CT SCANNER SYSTEM Neusoft Digital Medical Systems Co., Ltd., CN | JAK |
| Mar 26, 2002 | K020796 | CARD IQ ANALYSIS II GE Medical Systems | JAK |
| Mar 22, 2002 | K014240 | PRONTO Hitachi Medical Systems America, Inc. | JAK |
| Feb 15, 2002 | K020385 | CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A Toshiba America Medical Systems, In.C | JAK |
| Dec 7, 2001 | K013146 | VIATRONIC V3D CALCIUM SCORING Viatronix, Inc. | JAK |
| Nov 8, 2001 | K013561 | LIGHTSPEED 4.0 CT SCANNER SYSTEM GE Medical Systems | JAK |
| Nov 7, 2001 | K013522 | SOMATOM P30 CT SYSTEMS Siemens Medical Systems, Inc. | JAK |
| Nov 7, 2001 | K013521 | GEMINI IMAGING SYSTEM Adac Laboratories | JAK |
| Oct 30, 2001 | K013422 | CARDIQ FUNCTION GE Medical Systems | JAK |
| Oct 26, 2001 | K013381 | ADVANCED LUNG ANALYSIS-1 General Electric Co. | JAK |
| Oct 5, 2001 | K013214 | CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A Toshiba America Medical Systems, In.C | JAK |
| Oct 1, 2001 | K012238 | DOSERIGHT Philips Medical Systems North America Co. | JAK |
| Sep 25, 2001 | K012106 | ACCUIMAGE SMARTGATE UPGRADE Accuimage Diagnostics Corp. | JAK |
| Sep 13, 2001 | K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc. | JAK |
| Sep 7, 2001 | K012836 | MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM GE Medical Systems | JAK |
| Aug 10, 2001 | K012385 | HISPEED X/I SMART GANTRY OPTION Ge Medical Systems, Inc. | JAK |
| Aug 7, 2001 | K012313 | CT COLONOGRAPHY/NAVIGATOR2 Ge Medical Systems, Inc. | JAK |
| Aug 3, 2001 | K011447 | IN SPACE 3D Siemens Medical Solutions USA, Inc. | JAK |
| Jul 3, 2001 | K011141 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC Shimadzu Corp. | JAK |
| Jun 27, 2001 | K011180 | CT/MASTER, VERSION 1.0 Columbia Scientific, Inc. | JAK |
| Jun 15, 2001 | K010817 | MX8000 V5.0 CT SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
| May 16, 2001 | K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR E-Z-Em, Inc. | JAK |
| May 7, 2001 | K010813 | SIMPLICT Neorad AS | JAK |
| Mar 30, 2001 | K010641 | GE CT-PET SYSTEM Ge Medical Systems, Inc. | JAK |
| Jan 30, 2001 | K010042 | CT PERFUSION 2 General Electric Co. | JAK |
| Jan 23, 2001 | K003639 | VITREA 2 CT PERFUSION OPTION Vital Images, Inc. | JAK |
| Jan 18, 2001 | K003736 | MRI LINE MARKER I.Z.I. Corp. | JAK |
| Dec 27, 2000 | K003230 | V SCORE WITH AUTO GATE MODEL TBD Vital Images, Inc. | JAK |
| Nov 17, 2000 | K003408 | CT CORD IQ OPTION 1.0 GE Medical Systems | JAK |
| Oct 24, 2000 | K003152 | SOMATOM SMILE Siemens Medical Solutions USA, Inc. | JAK |
| Oct 12, 2000 | K003014 | SOMATOM EMOTION MS Siemens Medical Solutions USA, Inc. | JAK |
| Oct 10, 2000 | K002978 | LIGTHSPEED 3.0 CT SCANNER SYSTEM GE Medical Systems | JAK |
| Sep 22, 2000 | K002005 | BOLUSPRO ULTRA Marconi Medical Systems, Inc. | JAK |
| Aug 8, 2000 | K002258 | ULTRAGUIDE CT-GUIDE 1010 Ultraguide , Ltd. | JAK |
| Jun 30, 2000 | K001682 | VSCORE WITH EKG SIGNAL GATING Vital Images, Inc. | JAK |
| Jun 22, 2000 | K001088 | ULTRASIM CT SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
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