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 |
|---|---|---|---|
| Sep 24, 2013 | K131773 | BRILLIANCE ICT Philips Healthcare (Cleveland) | JAK |
| Aug 30, 2013 | K131576 | OPTIMA CT660 Ge Medical Systems, LLC | JAK |
| Aug 29, 2013 | K123540 | SYNGO CT PULMO 3D Siemens Medical Systems, Inc. | JAK |
| Aug 20, 2013 | K130960 | SURESUBTRACTION ORTHO Toshibamedical Systems Corporation | JAK |
| Jul 24, 2013 | K132087 | PERCUNAV SYSTEM Philips Health Care, CA | JAK |
| Jul 18, 2013 | K130224 | ICT Imris, Inc., CA | JAK |
| Jun 7, 2013 | K123576 | IMR SOFTWARE APPLICATION Philips Healthcare (Cleveland) | JAK |
| Jun 6, 2013 | K130645 | AQUILION PRIME, V5.00 Toshibamedical Systems Corporation | JAK |
| May 2, 2013 | K123500 | AQUILION LB TRITON V4.91 Toshibamedical Systems Corporation | JAK |
| Apr 2, 2013 | K123541 | SYNGO.CT NEURO PERFUSION Siemens Medical Systems, Inc. | JAK |
| Mar 29, 2013 | K123509 | SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| Mar 12, 2013 | K123584 | SYNGO, CT BONE READING Siemens Medical Solutions USA, Inc. | JAK |
| Feb 8, 2013 | K123596 | OPTIMA CT520 Ge Hangwei Medical Systems Co., Ltd., CN | JAK |
| Feb 1, 2013 | K121418 | PLANMED VERITY Planmed OY, FI | JAK |
| Dec 27, 2012 | K122909 | SYNGO SINGLE SOURCE DUAL ENGERY Siemens Medical Systems, Inc. | JAK |
| Dec 21, 2012 | K122106 | SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE Veran Medical Technologies, Inc. | JAK |
| Dec 20, 2012 | K123585 | SYNGO, CT CARDIAC FUNCTION Siemens Medical Solutions USA, Inc. | JAK |
| Dec 14, 2012 | K121498 | PERCUNAV Philips Health Care, CA | JAK |
| Nov 16, 2012 | K121792 | NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd. | JAK |
| Oct 26, 2012 | K120796 | SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER Superdimension, Inc. | JAK |
| Sep 26, 2012 | K113483 | ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION Philips Healthcare (Cleveland) | JAK |
| Sep 21, 2012 | K122109 | AQUILION ONE VISION, V4.90 Toshiba America Medical Systems, In.C | JAK |
| Sep 13, 2012 | K121827 | GSI VIEWER WITH VUE OPTION GE Medical Systems SCS | JAK |
| Sep 11, 2012 | K122471 | SOMATOM DEFINITION Siemens Medical Systems, Inc. | JAK |
| Aug 17, 2012 | K113715 | LUNG VOLUME ANALYSIS Toshibamedical Systems Corporation | JAK |
| Jul 26, 2012 | K121553 | AQUILION RXL Toshibamedical Systems Corporation | JAK |
| Jul 11, 2012 | K113421 | MINICAT Xoran Technologies, Inc. | JAK |
| Jun 18, 2012 | K120910 | CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL GE Medical Systems SCS, FR | JAK |
| Jun 13, 2012 | K120546 | AQUILION PREMIUM Toshiba Medical Systems Corporation, Japan | JAK |
| Jun 12, 2012 | K120833 | DISCOVERY CT750 HD Ge Medical Systems, LLC | JAK |
| May 23, 2012 | K120579 | SOMATOM DEFINITION EDGE Siemens Medical Systems, Inc. | JAK |
| May 23, 2012 | K113287 | SOMATOM PERSPECTIVE Siemens Medical Solutions USA, Inc. | JAK |
| May 8, 2012 | K121072 | SOMATOM DEFINITION FLASH Siemens Medical Systems, Inc. | JAK |
| May 7, 2012 | K113732 | IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) Brainlab AG, DE | JAK |
| May 3, 2012 | K113341 | GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| Apr 13, 2012 | K120331 | SYNGO CT DYNAMIC ANGIO Siemens AG Medical Solutions, DE | JAK |
| Apr 13, 2012 | K120300 | CT-GUIDE NEEDLE GUIDANCE SYSTEM Activiews, Ltd. | JAK |
| Apr 10, 2012 | K113548 | PEDCAT Curvebeam, LLC | JAK |
| Apr 10, 2012 | K113466 | AQUILION ONE Toshiba Medical Systems Coporation, Japan | JAK |
| Apr 10, 2012 | K112989 | AQUILION CXL Toshiba America Medical Systems, In.C | JAK |
| Apr 6, 2012 | K120710 | AQUILION PRIME Toshibamedical Systems Corporation | JAK |
| Jan 26, 2012 | K110066 | AQUILION PRIME Toshiba America Medical Systems, In.C | JAK |
| Dec 29, 2011 | K113342 | SOMATOM DEFINITION FLASH Siemens Medical Systems, Inc. | JAK |
| Nov 22, 2011 | K103424 | SAFIRE Siemens Medical Solutions USA, Inc. | JAK |
| Nov 10, 2011 | K113063 | CT-GUIDE NEEDLE GUIDANCE SYSTEM Activiews, Ltd. | JAK |
| Sep 9, 2011 | K103489 | GE VEO RECONSTRUCTION OPTION General Electric Co. | JAK |
| Aug 25, 2011 | K111633 | AQUILION LB MOVEMENT BASE KIT Toshiba America Medical Systems, In.C | JAK |
| Aug 18, 2011 | K112020 | SYNGO.CT VASCULAR ANALYSIS Siemens Medi Cal Solutions, Inc. | JAK |
| Jul 20, 2011 | K110227 | OPTIMA CT660 Ge Medical Systems, LLC | JAK |
| Jun 21, 2011 | K110812 | CT-GUIDE NEEDLE GUIDANCE SYSTEM Activiews, Ltd. | JAK |
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