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Radiology

14,649 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
1.5T GEM FLEX COIL (K113474)Neocoil, LLC2012-03-16
AIR-BAG SYSTEM (K112969)Niigata Mechatronics Co., Ltd.2012-03-14
ORTHOSIZE (K120115)Orthosize, LLC2012-03-14
SATURN 8000 (K120380)New Medical Co., Ltd.2012-03-09
QLAB QUANTIFICATION SOFTWARE (K120525)Philips Healthcare Group2012-03-09
SYNCHRONY RESPIRATORY TRACKING SYSTEM (K120233)Accuray Incorporated2012-03-09
SONOVISION (K113082)Peridot Technologies Ny, Inc.2012-03-08
BIOPSY POSITIONER (K113284)Fuji Film Medical Systems2012-03-07
HOLOGIC VISCERAL FAT SOFTWARE (K113356)Hologic, Inc.2012-03-06
SONICEYE ULTRASOUND TRANSDUCER (K113832)Blacktoe Medical Iii, Inc.2012-03-06
3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 (K113784)Eizo Nanao Corporation2012-03-02
C-THV SYSTEM (K113594)Paieon, Inc.2012-03-02
EUCLID (TM) TIER 1-GW ACCESS SYSTEM (K111426)Houston Medical Robotics2012-03-01
MOSAIQ ONCOLOGY INFORMATION SYSTEM (K120067)Impac Medical Systems, Inc.2012-02-28
TOSHIBA 1.5T CARDIAC COIL (K120290)Quality Electrodynamics2012-02-28
CATALYST (K113276)C-Rad Positioning AB2012-02-27
RADIFORCE RX240 (K113844)Eizo Nanao Corporation2012-02-27
X-RAY VVA (K112807)Medis Medical Imaging Systems BV2012-02-27
Q. FREEZE (MOTION VUE2) (K113408)Ge Medical Systems, LLC2012-02-24
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM (K112679)Materialise Dental NV2012-02-22
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM (K120321)Philips Health Care2012-02-17
SURFACE BEACON TRANSPONDERS (K112841)Calypso Medical Technologies, Inc.2012-02-16
CS IMAGING (K113419)Trophy2012-02-16
3DI (K113442)Shina Systems , Ltd.2012-02-16
VISIA NEURO (K113701)MeVis Medical Solutions AG2012-02-16
CADENS (TM) COLON (K111758)Dog Microsystems, Inc.2012-02-14
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM (K113403)GE Medical Systems SCS2012-02-14
REGIUS SIGMA2 (K120131)Konica Minolta Medical & Graphic, Inc.2012-02-10
SENSE MSK S 8CH 1.5T (K120122)Invivo Corporation2012-02-10
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A (K113612)Panasonic Healthcare Co., Ltd.2012-02-10
EPIGRAY (K112723)Dosisoft SA2012-02-08
PUREIMAGE ULTRASOUND TRANSMISSION GEL (K120156)Medline2012-02-08
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE (K113359)Chison Medical Imaging Co., Ltd.2012-02-03
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS (K112953)Teratech Corp.2012-02-03
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W (K111305)Meridian Medical Systems, LLC2012-01-31
CLARITY OBP SYSTEM (K111332)Elekta , Ltd.2012-01-30
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE (K112539)Leiker Regulatory & Quality Consulting2012-01-30
CAAS A-VALVE (K113076)Pie Medical Imaging BV2012-01-30
MCKESSON HORIZON CARDIOLOGY (K112720)Mckesson Israel , Ltd.2012-01-30
DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE (K111385)Qubyx Limited2012-01-30
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM (K113486)Volcano Corporation2012-01-27
AQUILION PRIME (K110066)Toshiba America Medical Systems, In.C2012-01-26
INFX-8000V WITH (K120073)Toshibamedical Systems Corporation2012-01-26
LOGICSCAN 64 LOGICSCAN 128 (K113184)Telemed2012-01-26
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K113632)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2012-01-25
SONIXTABLET ULTRASOUND SCANNER (K113663)Ultrasonix Medical Corporation2012-01-25
SWISSMEDA DENTAL PLANNING SYSTEM (K112251)Swissmeda AG2012-01-25
SUN 125C IONIZATION CHAMBER (K112981)Sun Nuclear Corp.2012-01-25
PANORAD, PANORAD SL (K113855)Imix Adr Finland OY2012-01-25
AERODR SYSTEM WITH P-21 (K113248)Konica Minolta Medical & Graphic, Inc.2012-01-17
VANTAGE TITAN 3T (K113093)Toshibamedical Systems Corporation2012-01-13
ACQA (K113086)Texas Medical Imaging Consultants2012-01-13
OPTIMA MR450W (K113490)Ge Medical Systems, LLC2012-01-13
TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT (K110971)Navotek Medical, Ltd.2012-01-10
VOLUSON E6/E8/E8EXPERT/E10 (K113758)GE Healthcare2012-01-10
RADIANCE (K112060)Gmv Aerospace and Defence S.A.2012-01-06
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE (K111861)Siemens Medical Systems USA2012-01-06
TOUCHPACS SUITE (K112008)Touch Medical Solutions, Inc.2012-01-06
ORTHOSCAN MOBILE DI MINI C-ARM (K113708)Orthoscan, Inc.2012-01-05
VISIA DYNAMIC REVIEW (K113337)MeVis Medical Solutions AG2011-12-30
SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING (K112778)Varian Medical Systems2011-12-29
SOMATOM DEFINITION FLASH (K113342)Siemens Medical Systems, Inc.2011-12-29
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA (K113630)Rayence Co., Ltd.2011-12-29
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT (K113680)Soma Access Systems, LLC2011-12-29
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM (K113381)Samsung Medison Co., Ltd.2011-12-29
GE LOGIQ I, LOGIQ E AND VIVID E (K113690)GE Healthcare2011-12-29
DELTAVIEW MODEL 2.1 (K111776)Riverain Medical Group,Llc2011-12-28
PROCEDURE REHEARSAL STUDIO(TM) (K112387)Simbionix , Ltd.2011-12-27
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL (K111673)Invivo Corporation2011-12-23
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) (K113443)Totoku Electric Co., Ltd.2011-12-23
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM (K110717)Konica Minolta Medical & Graphic, Inc.2011-12-23
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE (K112109)Ortho Kinematics, Inc.2011-12-22
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL (K110798)General Electric Company2011-12-22
SYNAPSE MPR FUSION (K113244)Fujifilm Medical System U.S.A., Inc.2011-12-22
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER (K111324)Agfa Healthcare N.V.2011-12-22
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER (K112776)Tomotherapy Incorporated2011-12-22
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256) (K113136)Totoku Electric Co., Ltd.2011-12-20
METRON-CP/MD (K103554)Eponatech, LLC2011-12-20
BIOGRAPH MCT FAMILY (K113448)Siemens Medical Solutions USA, Inc.2011-12-17
HD-IVUS ULTRASOUND IMAGING SYSTEM (K112997)Silicon Vally Medical Instruments, Inc.2011-12-17
8MP COLOR LCD MONITOR,RADIFORCE RX840 (K113226)Eizo Nanao Corporation2011-12-17
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER (K112770)Ninepoint Medical, Inc.2011-12-16
ONDEMAND3D (K113543)Cybermed, Inc.2011-12-16
INTEGRITY(TM) (K112613)Elekta Limited2011-12-16
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM (K113647)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2011-12-16
CLEARSTART SVM SYSTEM (K113541)Intio, Inc.2011-12-16
PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 (K100919)B-K Medical Aps2011-12-16
VIEW 1 IMAGING (K112480)Karl Storz Endoscopy America, Inc.2011-12-13
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM (K113034)GE Healthcare2011-12-13
ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING (K113102)Nucletron2011-12-12
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR (K111646)Fujifilm Medical System U.S.A., Inc.2011-12-08
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM (K113179)Siemens Medical Solutions USA, Inc., Ultrasound DI2011-12-07
DENTAL 3D PLANNING SOFTWARE (K113404)Symbyo Dental, LLC2011-12-06
BRIVO NM 615 (K113350)GE Healthcare2011-12-05
MOBILE MIM (K112930)Mim Software, Inc.2011-12-02
VANTAGE TITAN HSR (K112003)Toshibamedical Systems Corporation2011-12-02
FLAATZ 760 (K111655)Drtech Corp.2011-11-30
CENTRICITY CARDIO IMAGING (K112570)Ge Healthcare Integrated IT Solutions2011-11-30
5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 (K112354)Eizo Nanao Corporation2011-11-30
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K113153)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2011-11-28
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