JAK
822 FDA 510(k) clearances · Product code
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| Record | Firm | Date |
|---|---|---|
| syngo.CT Dental (K150785) | Siemens Medical Solutions USA, Inc. | 2015-05-18 |
| Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways (K143294) | Toshibamedical Systems Corporation | 2015-05-15 |
| Vitrea CT Myocardial Perfusion (K150104) | Vital Images, Inc. | 2015-04-17 |
| SOMATOM Definition Flash (VA48) (K143416) | Siemens Medical Solutions USA, Inc. | 2015-04-16 |
| SOMATOM Definition AS/AS+ (K143400) | Siemens Medical Solutions USA, Inc. | 2015-04-08 |
| SOMATOM Definition Edge (K143401) | Siemens Medical Solutions USA, Inc. | 2015-04-06 |
| SOMATOM Definition AS Open (VA48) (K143409) | Siemens Medical Solutions USA, Inc. | 2015-03-26 |
| Aquilion LB, TSX-201A/3, V6.0 (K150003) | Toshibamedical Systems Corporation | 2015-03-19 |
| Aquilion ONE Vision, v7.0 (K142465) | Toshibamedical Systems Corporation | 2015-03-10 |
| NewTom 5G (K142222) | Qr S.R.L. | 2015-01-26 |
| iMAR (K142584) | Siemens Medical Solutions USA, Inc. | 2015-01-16 |
| CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT (K143223) | Toshibamedical Systems Corporation | 2015-01-12 |
| NExCT 7 (K142697) | Neurologica Corporation | 2014-12-23 |
| CLEARVIEW (K133373) | Neusoft Medical Systems Co., Ltd. | 2014-12-03 |
| AQUILION PRIME, V6.00 (K141741) | Toshibamedical Systems Corporation | 2014-11-26 |
| PHILIPS IQON SPECTRAL CT (K133674) | Philips Healthcare (Cleveland) | 2014-11-21 |
| SYNGO, CT LIVER ANALYSIS (K133643) | Siemens Medi Cal Solutions, Inc. | 2014-11-13 |
| SYNGO CT SINGLE SOURCE DUAL ENERGY (K133677) | Siemens Medical Solutions USA, Inc. | 2014-10-16 |
| PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION (K133603) | Philips Medical Systems | 2014-09-25 |
| Lung Density Analysis (K141069) | Imbio, LLC | 2014-09-17 |
| SOMATOM SCOPE/SOMATOM SCOPE POWER (K140912) | Siemens Medical Solutions USA, Inc. | 2014-09-15 |
| AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT (K134025) | Toshibamedical Systems Corporation | 2014-09-05 |
| SURESUBTRACTION LUNG (K133324) | Toshiba Medical Systems Corporation, Japan | 2014-09-05 |
| SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT (K140232) | Siemens Medical Solutions USA, Inc. | 2014-08-14 |
| SYNGO, CT DUAL ENERGY (K133648) | Siemens Medical Solutions USA, Inc. | 2014-07-07 |
| PARI-PATH SURGICAL NAVIGATION SYSTEM (K133901) | Paritic, Inc. | 2014-06-27 |
| ADMIRE (K133646) | Siemens Medical Systems, Inc. | 2014-06-20 |
| CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION (K132524) | Philips Medical Systems | 2014-06-13 |
| MAXIO (K132108) | Perfint Healthcare Pvt, Ltd. | 2014-05-19 |
| SOMATOM PERSPECTIVE (K133590) | Siemens Medical Solutions USA, Inc. | 2014-04-30 |
| HEPATIC VCAR (K133649) | GE Medical Systems SCS | 2014-04-22 |
| SOMATOM FORCE (K133589) | Siemens Medical Solutions USA, Inc. | 2014-04-17 |
| REVOLUTION CT (K133705) | Ge Medical Systems, LLC | 2014-04-11 |
| SYNGO DUAL ENERGY SOFTWARE PACKAGE (K132902) | Siemens Medical Solutions USA, Inc. | 2014-04-07 |
| ASIR-V (K133640) | Ge Medical Systems, LLC | 2014-03-25 |
| ISYS 1 (U.S),ACCESSORY, NON-STERILE (K131433) | Isys Medizintechnik GmbH | 2014-03-11 |
| AQUILION ONE VISION (K133497) | Toshibamedical Systems Corporation | 2014-02-10 |
| DUAL ENERGY SYSTEM PACKAGE (K132813) | Toshibamedical Systems Corporation | 2014-02-06 |
| DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W (K132410) | Ge Medical Systems, LLC | 2014-01-17 |
| SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 (K133424) | Siemens Medical Solutions USA, Inc. | 2014-01-17 |
| CT PULMONARY ANALYSIS (K130552) | Qi Imaging, LLC | 2014-01-13 |
| SOMATOM DEFINITION AS OPEN (K130901) | Siemens Medical Systems, Inc. | 2014-01-02 |
| MYOPERFUSION (K132523) | Toshibamedical Systems Corporation | 2013-12-12 |
| AQUILION ONE VISION, V6.0 (K132222) | Toshibamedical Systems Corporation | 2013-11-07 |
| AIRO CT SYSTEM (K131431) | Mobius Imaging, LLC | 2013-09-26 |
| BRILLIANCE ICT (K131773) | Philips Healthcare (Cleveland) | 2013-09-24 |
| OPTIMA CT660 (K131576) | Ge Medical Systems, LLC | 2013-08-30 |
| SYNGO CT PULMO 3D (K123540) | Siemens Medical Systems, Inc. | 2013-08-29 |
| SURESUBTRACTION ORTHO (K130960) | Toshibamedical Systems Corporation | 2013-08-20 |
| PERCUNAV SYSTEM (K132087) | Philips Health Care | 2013-07-24 |
| ICT (K130224) | Imris, Inc. | 2013-07-18 |
| IMR SOFTWARE APPLICATION (K123576) | Philips Healthcare (Cleveland) | 2013-06-07 |
| AQUILION PRIME, V5.00 (K130645) | Toshibamedical Systems Corporation | 2013-06-06 |
| AQUILION LB TRITON V4.91 (K123500) | Toshibamedical Systems Corporation | 2013-05-02 |
| SYNGO.CT NEURO PERFUSION (K123541) | Siemens Medical Systems, Inc. | 2013-04-02 |
| SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM (K123509) | Hitachi Medical Systems America, Inc. | 2013-03-29 |
| SYNGO, CT BONE READING (K123584) | Siemens Medical Solutions USA, Inc. | 2013-03-12 |
| OPTIMA CT520 (K123596) | Ge Hangwei Medical Systems Co., Ltd. | 2013-02-08 |
| PLANMED VERITY (K121418) | Planmed OY | 2013-02-01 |
| SYNGO SINGLE SOURCE DUAL ENGERY (K122909) | Siemens Medical Systems, Inc. | 2012-12-27 |
| SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE (K122106) | Veran Medical Technologies, Inc. | 2012-12-21 |
| SYNGO, CT CARDIAC FUNCTION (K123585) | Siemens Medical Solutions USA, Inc. | 2012-12-20 |
| PERCUNAV (K121498) | Philips Health Care | 2012-12-14 |
| NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM (K121792) | Neusoft Medical Systems Co., Ltd. | 2012-11-16 |
| SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER (K120796) | Superdimension, Inc. | 2012-10-26 |
| ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION (K113483) | Philips Healthcare (Cleveland) | 2012-09-26 |
| AQUILION ONE VISION, V4.90 (K122109) | Toshiba America Medical Systems, In.C | 2012-09-21 |
| GSI VIEWER WITH VUE OPTION (K121827) | GE Medical Systems SCS | 2012-09-13 |
| SOMATOM DEFINITION (K122471) | Siemens Medical Systems, Inc. | 2012-09-11 |
| LUNG VOLUME ANALYSIS (K113715) | Toshibamedical Systems Corporation | 2012-08-17 |
| AQUILION RXL (K121553) | Toshibamedical Systems Corporation | 2012-07-26 |
| MINICAT (K113421) | Xoran Technologies, Inc. | 2012-07-11 |
| CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL (K120910) | GE Medical Systems SCS | 2012-06-18 |
| AQUILION PREMIUM (K120546) | Toshiba Medical Systems Corporation, Japan | 2012-06-13 |
| DISCOVERY CT750 HD (K120833) | Ge Medical Systems, LLC | 2012-06-12 |
| SOMATOM DEFINITION EDGE (K120579) | Siemens Medical Systems, Inc. | 2012-05-23 |
| SOMATOM PERSPECTIVE (K113287) | Siemens Medical Solutions USA, Inc. | 2012-05-23 |
| SOMATOM DEFINITION FLASH (K121072) | Siemens Medical Systems, Inc. | 2012-05-08 |
| IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) (K113732) | Brainlab AG | 2012-05-07 |
| GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K113341) | Hitachi Medical Systems America, Inc. | 2012-05-03 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K120300) | Activiews, Ltd. | 2012-04-13 |
| SYNGO CT DYNAMIC ANGIO (K120331) | Siemens AG Medical Solutions | 2012-04-13 |
| PEDCAT (K113548) | Curvebeam, LLC | 2012-04-10 |
| AQUILION ONE (K113466) | Toshiba Medical Systems Coporation, Japan | 2012-04-10 |
| AQUILION CXL (K112989) | Toshiba America Medical Systems, In.C | 2012-04-10 |
| AQUILION PRIME (K120710) | Toshibamedical Systems Corporation | 2012-04-06 |
| AQUILION PRIME (K110066) | Toshiba America Medical Systems, In.C | 2012-01-26 |
| SOMATOM DEFINITION FLASH (K113342) | Siemens Medical Systems, Inc. | 2011-12-29 |
| SAFIRE (K103424) | Siemens Medical Solutions USA, Inc. | 2011-11-22 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K113063) | Activiews, Ltd. | 2011-11-10 |
| GE VEO RECONSTRUCTION OPTION (K103489) | General Electric Co. | 2011-09-09 |
| AQUILION LB MOVEMENT BASE KIT (K111633) | Toshiba America Medical Systems, In.C | 2011-08-25 |
| SYNGO.CT VASCULAR ANALYSIS (K112020) | Siemens Medi Cal Solutions, Inc. | 2011-08-18 |
| OPTIMA CT660 (K110227) | Ge Medical Systems, LLC | 2011-07-20 |
| CT-GUIDE NEEDLE GUIDANCE SYSTEM (K110812) | Activiews, Ltd. | 2011-06-21 |
| DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS (K093581) | Ge Medical Systems, LLC | 2011-04-19 |
| SYNGO.CT CARDIAC FUNCTION (K110366) | Siemens AG | 2011-04-12 |
| SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K101888) | Hitachi Medical Systems America, Inc. | 2011-04-08 |
| BODYTOM NL 4000 (K102677) | Neurologica Corporation | 2011-03-24 |
| COMPUTED TOMOGRAPHY X-RAY SYSTEM (K102102) | VATECH Co., Ltd. | 2011-03-11 |
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