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Radiology

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

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RecordFirmDate
VERT-X (K061873)Direx Systems Corp.2006-08-18
HHF1 ECHELON MULTI-PURPOSE COIL (K061950)Hitachi Medical Systems America, Inc.2006-08-18
HD11 DIAGNOSTIC ULTRASOUND SYSTEM (K062247)Philips Ultrasound, Inc.2006-08-18
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 (K062107)Hologic, Inc.2006-08-18
XAMINER (K061595)Imaging Dynamics Company , Ltd.2006-08-17
MICROSELECTRON V3, MODEL 106.990 (K061354)Nucletron Corporation2006-08-17
SIEMENS ACUSON X500 ULTRASOUND SYSTEM (K061980)Siemens Medical Solutions USA, Inc.2006-08-17
CXDI-40EC (K062221)Canon, Inc.2006-08-17
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 (K061361)Faxitron X-Ray Corp.2006-08-15
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS (K061953)Ge Oec Medical Systems2006-08-15
DRY LASER IMAGER, DRYPRO MODEL 832 (K061999)Konica Minolta Medical & Graphic, Inc.2006-08-15
NEURO II-SE, MODELS OR-MB-DR AND OR-DR (K061916)Imris, Inc.2006-08-11
VOLCANO S51 FAMILY OF IMAGING SYSTEMS (K061215)Volcano Corporation2006-08-10
VITAL CONNECT 4.0 (K062154)Vital Images, Inc.2006-08-10
NEUROQUANT (K061855)Cortechs Labs, Inc.2006-08-10
XCAT; XCAT FOR NEURO (K061834)Xoran Technologies, Inc.2006-08-07
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM (K061755)Esaote Europe B.V.2006-08-07
MEDCHANNEL HTS SYSTEM (K061831)Medchannel, LLC2006-08-07
MONOCHROME LCD MONITOR, RADIFORCE, GS320 (K062053)Eizo Nanao Corporation2006-08-07
SONIX ULTRASOUND SCANNER (K061827)Ultrasonix Medical Corporation2006-08-04
BEST STRAND AND BEST SPACER (K061638)Best Medical International, Inc.2006-08-04
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 (K061952)Invivo2006-07-28
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS (K061561)Hologic, Inc.2006-07-28
BIOLUCENT APPLICATOR, MODEL RTA-XX (K061241)Biolucent, Inc.2006-07-28
MRGFUS GENERAL PURPOSE AND BREAST COIL (K061715)Insightec Txsonics, Inc.2006-07-28
IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K061913)Ion Beam Applications S.A.2006-07-28
DIAGNOSOFT HARP (K061368)Diagnosoft, Inc.2006-07-28
CALYPSO 4D LOCALIZATION SYSTEM (K060906)Calypso Medical Technologies, Inc.2006-07-28
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY (K061930)Fonar Corp.2006-07-28
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (K061643)Shimadzu Medical Systems2006-07-27
SYNGO MULTIMODALITY WORKPLACE (K061964)Siemens AG Medical Solutions2006-07-27
TOPSLANE DMLC (K060187)Topslane International, LLC2006-07-27
INTEGRA RADIONICS XKNIFE RT 4 (K061893)Integra Radionics, Inc.2006-07-25
SYNGO EXPERT-1 (K061449)Siemens Medical Solution2006-07-25
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO (K061637)Shimadzu Medical Systems2006-07-25
ERAD PACS (K061421)Erad, Inc.2006-07-25
VARISOURCE 200 HDR AFTERLOADER (K061582)Varian Medical Systems, Inc.2006-07-25
21.3 INCH MONOCHROME LCD MONITOR (K061947)Nec Display Solutions , Ltd.2006-07-25
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA (K061429)Esaote, S.p.A.2006-07-25
MAGIS1;MAGIS2 (K061713)Direx Systems Corp.2006-07-21
QUANTIVA (K061418)Tomographix IP , Ltd.2006-07-21
NOMOSSTAT, VERSION 1.0 (K060895)Nomos Corp.2006-07-21
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) (K061447)Totoku Electric Co., Ltd.2006-07-21
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM (K061946)Siemens Medical Solutions USA, Inc.2006-07-21
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO (K061641)Shimadzu Medical Systems2006-07-14
LIGHTSPEED 7.1 CT SCANNER SYSTEM (K061817)Ge Medical Systems, LLC2006-07-12
IPLAN RT DOSE (K053584)Brainlab AG2006-07-12
GE VOLUSON E8 ULTRASOUND SYSTEM (K061682)General Electric Co.2006-07-12
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM (K061534)Ziehm Imaging, Inc.2006-07-07
ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM (K061310)Ziehm Imaging, Inc.2006-07-07
LEKSELL GAMMAPLAN (K061540)Elekta Instrument AB2006-07-05
GE VIVID - I (K061525)General Electric Co.2006-07-03
SCENIUM 1.1 (K061545)Siemens Molecular Imaging, Ltd.2006-06-30
CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM (K061488)Shantou Institute of Ultrasonic Instruments (Siui2006-06-30
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 (K061538)Alara, Inc.2006-06-30
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS (K061672)Fujifilm Medical Systems U.S.A, Inc.2006-06-29
SYNGO TRUED, MODEL VC10A (K061671)Siemens Medical Solutions2006-06-29
VITREA, VERSION 3.9 (K061624)Vital Images, Inc.2006-06-27
P.D (K061440).Decimal, Inc.2006-06-27
AUTOBONE2 (K061625)GE Healthcare2006-06-26
VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM (K060483)Volcano Corporation2006-06-23
FULLCARD ANALYSIS (K061587)GE Healthcare2006-06-23
DIGITAL PRINTER P6000D SERIES, MODEL P6000DU (K061302)Mitsubishi Electric Corporation Kyoto Works2006-06-23
NEMIO XG, SAA-580A (K061605)Toshiba America Medical Systems, In.C2006-06-22
ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM (K061203)Ziehm Imaging, Inc.2006-06-19
INSIGHT HEAD COIL (K061281)Insight Neuroimaging Systems, LLC2006-06-19
SIGMA 5000 SERIES, IMAGIC (K061437)Kontron Medical Systems Sas2006-06-14
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER (K061051)Sicel Technologies, Inc.2006-06-13
BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 (K061255)Kyron Clinical Imaging, Inc.2006-06-13
CPIVISION DIGITAL IMAGING SYSTEM (K061173)Communications & Power Industries Canada, Inc.2006-06-09
M-VU CAD STATION (K061160)Vucomp, Inc.2006-06-09
GALILEOS IMPLANT, V 1.0 (K061472)Sicat GmbH & Co. KG2006-06-09
PRECISION THUNIS 800+ (K061028)Ge Medical Systems, LLC2006-06-07
COHERENCE DOSIMETRIST, MODEL 2.2 (K061097)Siemens Medical Solutions USA, Inc.2006-06-07
20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204) (K061061)Tokotu Electric Co., Ltd.2006-06-07
QUIX DIGITAL RADIOGRAPHIC UPGRADE (K052661)Edge Medical Devices , Ltd.2006-06-07
INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT (K061163)Ge Medical Systems, LLC2006-06-07
ART BRACHYTHERAPY APPLICATOR (K060299)Advanced Radiation Therapy, LLC2006-06-06
CTS-7700 (K061083)Shantou Institute of Ultrasonic Instuments2006-06-06
TIGERVIEW PROFESSIONAL (K061035)Televere Systems2006-06-05
IKOENGELO (K061006)Ikoetech, LLC2006-06-05
BRILLIANCE VOLUME (K060937)Philips Medical Systems (Cleveland), Inc.2006-06-05
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 (K061129)General Electric Co.2006-06-01
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K061189)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-06-01
CENTRICITY AW SUITE OPTION (K061372)Ge Healthcare Information Technologies2006-05-30
CARDIQ FUSION (K061370)GE Healthcare2006-05-30
QLAB QUANTIFICATION SOFTWARE (K061396)Philips Ultrasound, Inc.2006-05-30
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 (K061170)Resonance Innovations, LLC2006-05-25
MEDICAL DISPLAY, MDC1900-1LG (1LR) (K061305)Chi Lin Technology Co., Ltd.2006-05-25
VOXAR 3D ENTERPRISE WITH CARDIAMETRIX (K061326)Barcoview Mis Edinburgh2006-05-25
MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR (K061303)Chi Lin Technology Co., Ltd.2006-05-25
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035 (K061132)Neusoft Medical Systems Co., Ltd.2006-05-24
MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 (K060827)Esaote, S.p.A.2006-05-19
3MATIC (K060950)Materialise NV2006-05-18
MIM 4.0 (NEURO (K060816)Mimvista Corp.2006-05-16
SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM (K061213)Medison Co., Ltd.2006-05-16
AVANZA (K060870)Mds Nordion2006-05-15
AQUARIUSAPS SERVER (K061214)Terarecon,Inc.2006-05-15
TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K061140)Varian Medical Systems2006-05-15
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING (K061187)Toshiba America Medical Systems, In.C2006-05-12
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