meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2012-05-23

Clearances · page 59 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121384 MYLABSOGNO Esaote, S.p.A. IYN Class II 2012-05-23
K120487 VANTAGE TITAN 3T Toshibamedical Systems Corporation LNH Class II 2012-05-23
K112527 UNIVERSAL DIGITAL INTERFACE (UDI) 1717 Meridian Medical Systems, LLC MQB Class II 2012-05-22
K111862 VIEWRAY SYSTEM Viewray, Incorporated IYE Class II 2012-05-22
K121138 ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solution IYN Class II 2012-05-17
K113281 MRI SYTEMS Shenzhen Anke High-Tech Co., Ltd. LNH Class II 2012-05-17
K121223 QLAB WITH FHN AND VPQ PLUG-IN Philips Ultrasound, Inc. LLZ Class II 2012-05-15
K121132 EZSENSOR P DIGITAL INTRAORAL SENSOR Humanray Co,Ltd MQB Class II 2012-05-10
K121072 SOMATOM DEFINITION FLASH Siemens Medical Systems, Inc. JAK Class II 2012-05-08
K120637 SYNAPSE 3D BRAIN PERFUSION Fujifilm Medical System U.S.A., Inc. LLZ Class II 2012-05-08
K113732 IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) Brainlab AG JAK Class II 2012-05-07
K120020 VIVIX-S Vieworks Co., Ltd. MQB Class II 2012-05-04
K120344 RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE Radiadyne, LLC (Specification Developer) JAQ Class II 2012-05-03
K120335 EMBRACE THERMOPLASTIC Bionix Development Corp. IYE Class II 2012-05-03
K113812 ATAL-8 Atlaim MQB Class II 2012-05-03
K113341 GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. JAK Class II 2012-05-03
K113511 ECHOSTAR SPICA 1.5T MR SYSTEM Alltech Medical Systems America, Inc. LNH Class II 2012-05-02
K113145 ECHELON OVAL MRI SYSTEM Hitachi Medical Systems America, Inc. LNH Class II 2012-05-01
K120748 SPEEDUP SOFTWARE OPTION Esaote, S.p.A. LNH Class II 2012-05-01
K113286 ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS Ge Medical Systems Lunar KGI Class II 2012-04-27
K120741 VOLUSON S6, VOLUSON S8 GE Healthcare IYN Class II 2012-04-27
K120341 PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM Varian Medical Systems, Inc. JAQ Class II 2012-04-27
K113599 SURGICASE CONNECT Materialise NV LLZ Class II 2012-04-27
K113616 ACCUDXA2 Lone Oak Medical Technologies, LLC KGI Class II 2012-04-27
K111824 FLAT PANEL DETECTOR Canon Inc. -Medical Equipment Group MQB Class II 2012-04-23
K120207 VISIA MeVis Medical Solutions AG LLZ Class II 2012-04-23
K113240 3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W Eizo Nanao Corporation LLZ Class II 2012-04-20
K120196 OLEA SPHERE Olea Medical LLZ Class II 2012-04-19
K120699 DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2012-04-19
K112286 NOVAC 11 New Radiant Technology S.P.A. IYE Class II 2012-04-19
K121019 OPTIMA NM/CT 640 GE Healthcare KPS Class II 2012-04-19
K120076 RESOLUTIONMD WEB Calgary Scientific, Inc. LLZ Class II 2012-04-19
K120201 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Ge Vingmed Ultrasound AS IYO Class II 2012-04-19
K120234 EZONO 3000 Life-Tech, Inc. IYN Class II 2012-04-19
K120718 INSTAPACS/INSTARISPACS Meddiff Technologies Pvt. , Ltd. LLZ Class II 2012-04-19
K120407 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 Eizo Nanao Corporation LLZ Class II 2012-04-19
K121010 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2012-04-19
K120255 PHILIPS MICRODOSE Philips Digital Mammography Sweden AB MUE Class II 2012-04-19
K120859 PRE-LOADED GOLD VISICOIL CK MARKER Radiomed Corporation KXK Class II 2012-04-19
K110840 LIAC Sordina S.P.A. IYE Class II 2012-04-17
K120367 3MENSIO WORKSTATION Pie Medical Imaging BV LLZ Class II 2012-04-17
K120034 RADIOGRAPHIC X-RAY SYSTEM Orich Medical Equipment (Tianjin Co., Ltd. KPR Class II 2012-04-17
K120315 SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION Siemens Medical Solutions USA, Inc. LLZ Class II 2012-04-13
K120062 DRX-REVOLUTION MOBILE X-RAY SYSTEM Carestream Health, Inc. IZL Class II 2012-04-13
K120300 CT-GUIDE NEEDLE GUIDANCE SYSTEM Activiews, Ltd. JAK Class II 2012-04-13
K120135 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 Tomtec Imaging Systems GmbH LLZ Class II 2012-04-13
K110590 INTRABEAM NEEDLE APPLICATOR Carl Zeiss Surgical GmbH JAD Class II 2012-04-13
K120331 SYNGO CT DYNAMIC ANGIO Siemens AG Medical Solutions JAK Class II 2012-04-13
K120703 ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM Zonare Medical Systems, Inc. IYN Class II 2012-04-13
K102327 CLEARVISION DR 7000F Jpi Healthcare Co, Ltd. MQB Class II 2012-04-13
K120161 ALPHAPOINT IMAGING SOFTWARE Radlogics, Inc. LLZ Class II 2012-04-13
K113548 PEDCAT Curvebeam, LLC JAK Class II 2012-04-10
K112989 AQUILION CXL Toshiba America Medical Systems, In.C JAK Class II 2012-04-10
K113466 AQUILION ONE Toshiba Medical Systems Coporation, Japan JAK Class II 2012-04-10
K120477 AEROSYNC FOR AERODR SYSTEM Konica Minolta Medical & Graphic, Inc. MQB Class II 2012-04-09
K120387 RAYSTATION Raysearch Laboratories AB MUJ Class II 2012-04-06
K120721 EOS Eos Imaging MQB Class II 2012-04-06
K120709 THE DOME GX4MP COLOR NONITOR Nds Surgical Imaging LLZ Class II 2012-04-06
K120187 MULTI-MODALITY IMAGE FUSION Igt, LLC Dba Eigen LLZ Class II 2012-04-06
K120388 INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM Hologic, Inc. OXO Class II 2012-04-06
K120361 SYNAPSE 3D BASE TOOLS Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2012-04-06
K120613 OEC 9900 ELITE Ge Healthcare Surgery GE Oec Medical Systems, Inc. OXO Class II 2012-04-06
K120710 AQUILION PRIME Toshibamedical Systems Corporation JAK Class II 2012-04-06
K120221 GE ECHOPAC GE Healthcare LLZ Class II 2012-03-30
K113365 INFANT ARRAY Advanced Imaging Research Dba Sree Medical Systems MOS Class II 2012-03-29
K120627 TOSHIBA 1.5T QD HEAD COIL Quality Electrodynamics MOS Class II 2012-03-29
K120778 BRIVO MR355 Ge Hangwei Medical Systems Co., Ltd. LNH Class II 2012-03-27
K120484 VISIA ONCOLOGY MeVis Medical Solutions AG LLZ Class II 2012-03-27
K113304 BLADDER SCANNER MEDA Co., Ltd. IYO Class II 2012-03-23
K120363 SYNGO RT INTERFACE Siemens Medical Solutions USA, Inc. MUJ Class II 2012-03-20
K120060 E-CUBE 9 Alpinion Medical Systems Co., Ltd. IYN Class II 2012-03-16
K113474 1.5T GEM FLEX COIL Neocoil, LLC MOS Class II 2012-03-16
K113766 CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN Varian Medical Systems, Inc. JAQ Class II 2012-03-16
K120115 ORTHOSIZE Orthosize, LLC LLZ Class II 2012-03-14
K112969 AIR-BAG SYSTEM Niigata Mechatronics Co., Ltd. LHN Class II 2012-03-14
K120233 SYNCHRONY RESPIRATORY TRACKING SYSTEM Accuray Incorporated IYE Class II 2012-03-09
K120380 SATURN 8000 New Medical Co., Ltd. MQB Class II 2012-03-09
K120525 QLAB QUANTIFICATION SOFTWARE Philips Healthcare Group LLZ Class II 2012-03-09
K113082 SONOVISION Peridot Technologies Ny, Inc. LLZ Class II 2012-03-08
K113284 BIOPSY POSITIONER Fuji Film Medical Systems IZH Class II 2012-03-07
K113356 HOLOGIC VISCERAL FAT SOFTWARE Hologic, Inc. KGI Class II 2012-03-06
K113832 SONICEYE ULTRASOUND TRANSDUCER Blacktoe Medical Iii, Inc. ITX Class II 2012-03-06
K113784 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 Eizo Nanao Corporation LLZ Class II 2012-03-02
K113594 C-THV SYSTEM Paieon, Inc. IZI Class II 2012-03-02
K111426 EUCLID (TM) TIER 1-GW ACCESS SYSTEM Houston Medical Robotics ITX Class II 2012-03-01
K120067 MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc. IYE Class II 2012-02-28
K120290 TOSHIBA 1.5T CARDIAC COIL Quality Electrodynamics MOS Class II 2012-02-28
K113844 RADIFORCE RX240 Eizo Nanao Corporation LLZ Class II 2012-02-27
K113276 CATALYST C-Rad Positioning AB IYE Class II 2012-02-27
K112807 X-RAY VVA Medis Medical Imaging Systems BV LLZ Class II 2012-02-27
K113408 Q. FREEZE (MOTION VUE2) Ge Medical Systems, LLC KPS Class II 2012-02-24
K112679 SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM Materialise Dental NV LLZ Class II 2012-02-22
K120321 CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM Philips Health Care IYN Class II 2012-02-17
K113419 CS IMAGING Trophy LLZ Class II 2012-02-16
K113442 3DI Shina Systems , Ltd. LLZ Class II 2012-02-16
K113701 VISIA NEURO MeVis Medical Solutions AG LLZ Class II 2012-02-16
K112841 SURFACE BEACON TRANSPONDERS Calypso Medical Technologies, Inc. IYE Class II 2012-02-16
K111758 CADENS (TM) COLON Dog Microsystems, Inc. LLZ Class II 2012-02-14
K113403 GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM GE Medical Systems SCS OWB Class II 2012-02-14
K120122 SENSE MSK S 8CH 1.5T Invivo Corporation MOS Class II 2012-02-10

14,721 clearances in the Radiology panel. Data: openFDA.