meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
20
Latest Decision
2012-02-10

Clearances · page 60 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113612 AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A Panasonic Healthcare Co., Ltd. IYN Class II 2012-02-10
K120131 REGIUS SIGMA2 Konica Minolta Medical & Graphic, Inc. MQB Class II 2012-02-10
K112723 EPIGRAY Dosisoft SA MUJ Class II 2012-02-08
K120156 PUREIMAGE ULTRASOUND TRANSMISSION GEL Medline ITX Class II 2012-02-08
K112953 TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS Teratech Corp. IYN Class II 2012-02-03
K113359 CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE Chison Medical Imaging Co., Ltd. IYN Class II 2012-02-03
K111305 UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W Meridian Medical Systems, LLC MQB Class II 2012-01-31
K111332 CLARITY OBP SYSTEM Elekta , Ltd. IYE Class II 2012-01-30
K111385 DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE Qubyx Limited LLZ Class II 2012-01-30
K112539 CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE Leiker Regulatory & Quality Consulting IYO Class II 2012-01-30
K112720 MCKESSON HORIZON CARDIOLOGY Mckesson Israel , Ltd. LLZ Class II 2012-01-30
K113076 CAAS A-VALVE Pie Medical Imaging BV LLZ Class II 2012-01-30
K113486 VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM Volcano Corporation IYO Class II 2012-01-27
K110066 AQUILION PRIME Toshiba America Medical Systems, In.C JAK Class II 2012-01-26
K113184 LOGICSCAN 64 LOGICSCAN 128 Telemed IYN Class II 2012-01-26
K120073 INFX-8000V WITH Toshibamedical Systems Corporation OWB Class II 2012-01-26
K113663 SONIXTABLET ULTRASOUND SCANNER Ultrasonix Medical Corporation IYN Class II 2012-01-25
K113632 DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. IYO Class II 2012-01-25
K112251 SWISSMEDA DENTAL PLANNING SYSTEM Swissmeda AG LLZ Class II 2012-01-25
K112981 SUN 125C IONIZATION CHAMBER Sun Nuclear Corp. LHN Class II 2012-01-25
K113855 PANORAD, PANORAD SL Imix Adr Finland OY KPR Class II 2012-01-25
K113248 AERODR SYSTEM WITH P-21 Konica Minolta Medical & Graphic, Inc. KPR Class II 2012-01-17
K113086 ACQA Texas Medical Imaging Consultants KPS Class II 2012-01-13
K113490 OPTIMA MR450W Ge Medical Systems, LLC LNH Class II 2012-01-13
K113093 VANTAGE TITAN 3T Toshibamedical Systems Corporation LNH Class II 2012-01-13
K110971 TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT Navotek Medical, Ltd. IYE Class II 2012-01-10
K113758 VOLUSON E6/E8/E8EXPERT/E10 GE Healthcare IYE Class II 2012-01-10
K111861 SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE Siemens Medical Systems USA LLZ Class II 2012-01-06
K112008 TOUCHPACS SUITE Touch Medical Solutions, Inc. LLZ Class II 2012-01-06
K112060 RADIANCE Gmv Aerospace and Defence S.A. MUJ Class II 2012-01-06
K113708 ORTHOSCAN MOBILE DI MINI C-ARM Orthoscan, Inc. OXO Class II 2012-01-05
K113337 VISIA DYNAMIC REVIEW MeVis Medical Solutions AG LNH Class II 2011-12-30
K113680 SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT Soma Access Systems, LLC IYO Class II 2011-12-29
K112778 SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING Varian Medical Systems IYE Class II 2011-12-29
K113342 SOMATOM DEFINITION FLASH Siemens Medical Systems, Inc. JAK Class II 2011-12-29
K113690 GE LOGIQ I, LOGIQ E AND VIVID E GE Healthcare IYN Class II 2011-12-29
K113381 MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2011-12-29
K113630 DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA Rayence Co., Ltd. MQB Class II 2011-12-29
K111776 DELTAVIEW MODEL 2.1 Riverain Medical Group,Llc LLZ Class II 2011-12-28
K112387 PROCEDURE REHEARSAL STUDIO(TM) Simbionix , Ltd. LLZ Class II 2011-12-27
K110717 KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM Konica Minolta Medical & Graphic, Inc. MUE Class II 2011-12-23
K113443 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) Totoku Electric Co., Ltd. LLZ Class II 2011-12-23
K111673 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL Invivo Corporation MOS Class II 2011-12-23
K112776 TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER Tomotherapy Incorporated MUJ Class II 2011-12-22
K111324 CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER Agfa Healthcare N.V. MUE Class II 2011-12-22
K112109 THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE Ortho Kinematics, Inc. LLZ Class II 2011-12-22
K110798 SENOGRAPHE DS, SENOGRAPHE ESSENTIAL General Electric Company MUE Class II 2011-12-22
K113244 SYNAPSE MPR FUSION Fujifilm Medical System U.S.A., Inc. LLZ Class II 2011-12-22
K103554 METRON-CP/MD Eponatech, LLC LLZ Class II 2011-12-20
K113136 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) Totoku Electric Co., Ltd. LLZ Class II 2011-12-20
K113448 BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc. KPS Class II 2011-12-17
K113226 8MP COLOR LCD MONITOR,RADIFORCE RX840 Eizo Nanao Corporation LLZ Class II 2011-12-17
K112997 HD-IVUS ULTRASOUND IMAGING SYSTEM Silicon Vally Medical Instruments, Inc. IYN Class II 2011-12-17
K113541 CLEARSTART SVM SYSTEM Intio, Inc. LLZ Class II 2011-12-16
K113543 ONDEMAND3D Cybermed, Inc. LLZ Class II 2011-12-16
K112770 NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER Ninepoint Medical, Inc. NQQ Class II 2011-12-16
K100919 PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 B-K Medical Aps IYN Class II 2011-12-16
K113647 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2011-12-16
K112613 INTEGRITY(TM) Elekta Limited IYE Class II 2011-12-16
K113034 GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM GE Healthcare IZI Class II 2011-12-13
K112480 VIEW 1 IMAGING Karl Storz Endoscopy America, Inc. LLZ Class II 2011-12-13
K113102 ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING Nucletron MUJ Class II 2011-12-12
K111646 ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR Fujifilm Medical System U.S.A., Inc. MUE Class II 2011-12-08
K113179 ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI IYN Class II 2011-12-07
K113404 DENTAL 3D PLANNING SOFTWARE Symbyo Dental, LLC LLZ Class II 2011-12-06
K113350 BRIVO NM 615 GE Healthcare KPS Class II 2011-12-05
K112930 MOBILE MIM Mim Software, Inc. LLZ Class II 2011-12-02
K112003 VANTAGE TITAN HSR Toshibamedical Systems Corporation LNH Class II 2011-12-02
K112354 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 Eizo Nanao Corporation LLZ Class II 2011-11-30
K112570 CENTRICITY CARDIO IMAGING Ge Healthcare Integrated IT Solutions LLZ Class II 2011-11-30
K111655 FLAATZ 760 Drtech Corp. KPR Class II 2011-11-30
K113153 DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2011-11-28
K103483 INGENUITY TF PET/MR Philips Healthcare (Cleveland) OUO Class II 2011-11-23
K113280 CAROTID COIL GE 1.5T Tursiop Technologies, LLC MOS Class II 2011-11-23
K112751 SDX-4343CS Samsung Mobile Display Co., Ltd. MQB Class II 2011-11-23
K111242 MAGNETOM AERA AND MAGNETOM SKYRA Siemens Medical Solutions USA, Inc. LNH Class II 2011-11-23
K112210 FRAXION Medical Intelligence Medizintechnik GmbH IYE Class II 2011-11-22
K113027 SYNGO AORTIC VALVEGUIDE SOFTWARE Siemens Medical Solutions USA, Inc. OWB Class II 2011-11-22
K103424 SAFIRE Siemens Medical Solutions USA, Inc. JAK Class II 2011-11-22
K113052 INFINIX-CCI Toshiba America Medical Systems, In.C MQB Class II 2011-11-22
K113029 SYNGO VIA MI WORKFLOWS Siemens Medical Solutions USA, Inc. LLZ Class II 2011-11-18
K112531 VITREA CT MYOCARDIAL ANALYSIS Vital Images, Inc. LLZ Class II 2011-11-18
K112002 CAROTID COIL Shanghai Chenguang Medical Technologies Co, Ltd. MOS Class II 2011-11-18
K111642 ONCO TRAC MODEL 1, 2, 4 Translational Sciences Corporation LLZ Class II 2011-11-18
K112420 ONCENTRA PROSTATE 4.0 Nucletron JAQ Class II 2011-11-18
K112132 KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM Medicatech USA MQB Class II 2011-11-18
K110596 MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM Wide Corporation LLZ Class II 2011-11-18
K112768 CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING Calypso Medical Technologies, Inc. LHN Class II 2011-11-18
K113156 SONOSITE EDGE ULTRASOUND SYSTEM Sonosite,Inc. IYO Class II 2011-11-15
K112839 VARIAN HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems IYE Class II 2011-11-14
K112558 DIGITAL FLAT PANEL X-RAY DETECTOR Samsung Mobile Display Co., Ltd. MQB Class II 2011-11-10
K113063 CT-GUIDE NEEDLE GUIDANCE SYSTEM Activiews, Ltd. JAK Class II 2011-11-10
K112145 MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 Totoku Electric Co., Ltd. LLZ Class II 2011-11-07
K112602 S6 DIAGNOSTIC ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2011-11-07
K111161 PERFSCAPE V2.0 Olea Medical LLZ Class II 2011-11-04
K110765 FXA (TM) Aces GmbH LLZ Class II 2011-11-04
K100784 UC-CARE NAVIGO SYTEM UC-CARE , Ltd. LLZ Class II 2011-11-01
K112466 4MP COLOR LCD MONITOR, RADIFORCERX430 Eizo Nanao Corporation LLZ Class II 2011-10-27
K112670 DX-D 600 Agfa Healthcare N.V. KPR Class II 2011-10-27
K111434 GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L Giotto USA, LLC MUE Class II 2011-10-27

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