meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2011-03-25

Clearances · page 63 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102196 COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. OAS Class II 2011-03-25
K110332 CLEARCANVAS RIS / PACS Clearcanvas, Inc. LLZ Class II 2011-03-24
K102677 BODYTOM NL 4000 Neurologica Corporation JAK Class II 2011-03-24
K101887 CONFIDENT SURGERY SUITE 300, MODEL CSS300 Surgiceye GmbH IZD Class I 2011-03-22
K102533 ROTATING GAMMA SYSTEM INFINI (INFINI) Masep Medical Science & Tech.Development (Shenzhen IWB Class II 2011-03-22
K103411 IDEAL IQ SOFTWARE OPTION GE Medical Systems LNH Class II 2011-03-22
K103711 ORTHOPHOS XG 3D / CEPH Sirona Dental Systems GmbH OAS Class II 2011-03-22
K110151 ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T Philips Health Care LNH Class II 2011-03-22
K110601 SENTINELLA 102 General Equipment For Medical Imaging, S.A. IYX Class I 2011-03-18
K110482 PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS Teratech Corp. IYN Class II 2011-03-18
K103546 AYCAN WORKSTATION OSIRIX PRO Aycan Digitalsysteme GmbH LLZ Class II 2011-03-17
K103416 NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM Infimed, Inc. OWB Class II 2011-03-17
K103246 IPLAN RT Brainlab AG MUJ Class II 2011-03-16
K103265 NHANES WHOLE BODY DXA REFERENCE DATABASE Hologic, Inc. KGI Class II 2011-03-16
K103720 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2011-03-16
K110108 MODALIXX Ampronix, Inc. LLZ Class II 2011-03-16
K102253 ECHO BLASTER Telemed IYO Class II 2011-03-14
K103471 UBM PLUS Accutome, Inc. IYN Class II 2011-03-14
K102102 COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. JAK Class II 2011-03-11
K110511 E4D COMPASS D4D Technologies LLZ Class II 2011-03-11
K103146 ISOGRAY TREATMENT PLANNING SYSTEM Dosisoft SA MUJ Class II 2011-03-11
K103148 AIDA DIAGNOSTIC ULTRASOUND SYSTEM Panasonic Healthcare Co., Ltd. IYO Class II 2011-03-11
K103649 VOLUSON S6, VOLUSON S8 GE Healthcare IYN Class II 2011-03-09
K103480 THORACIC VCAR Ge Medical Systems, LLC LLZ Class II 2011-03-07
K103335 GEM OPTION FOR 1.5 MRI SYSTEMS GE Healthcare MOS Class II 2011-03-07
K103458 VIEWPOINT 6 GE Healthcare LLZ Class II 2011-03-04
K103127 SOMATOM DEFINITION AS Siemens Medical Solutions USA, Inc. JAK Class II 2011-03-04
K103792 BARCO MAMMO TOMOSYNTHESIS Barco N.V. LLZ Class II 2011-03-04
K103687 SYNAPSE 3D CEREBRAL ANALYSIS Fujifilm Medical System U.S.A., Inc. LLZ Class II 2011-03-04
K102474 FLAATZ 750E Drtech Corp. MQB Class II 2011-03-04
K102642 SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO Sonoscape Company Limited IYN Class II 2011-03-04
K103679 AXIS PACS, HMS PACS Axis Health Care, LLC LLZ Class II 2011-03-03
K103397 ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2011-02-25
K103185 TOSHIBA 1.5T EXTRA LARGE KNEE COIL Quality Electrodynamics MOS Class II 2011-02-25
K103449 BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS Riverpoint Medical KXK Class II 2011-02-25
K110120 ECHELON RAPID CARDIAC COIL Hitachi Medical Systems America, Inc. MOS Class II 2011-02-25
K103059 TROPHON Nanosonics Limited OUJ Class II 2011-02-24
K103576 MIM 5.2 (BRACHY) Mim Software, Inc. LLZ Class II 2011-02-18
K102259 DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH Co., Ltd. JAK Class II 2011-02-18
K110238 G-SCAN Esaote, S.p.A. LNH Class II 2011-02-17
K110207 ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2011-02-17
K102637 DYNAREX ULTRASOUND GEL Dynarex Corporation MUI Class II 2011-02-16
K103238 1.5T OPTIMA MR430S Ge Medical Systems, LLC LNH Class II 2011-02-11
K102321 DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP Samsung Mobile Display Co., Ltd. MQB Class II 2011-02-11
K103761 VISUALIZE: VASCULAR The Medipattern Corporation LLZ Class II 2011-02-11
K110093 SUPERDIMENSION MARKER DELIVERY KIT Superdimension, Inc. JAK Class II 2011-02-11
K103330 BRIVO MR355, OPTIMA MR360 Ge Hangwei Medical Systems Co., Ltd. LNH Class II 2011-02-11
K110202 FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB Fujifilm Medical System U.S.A., Inc. ITX Class II 2011-02-08
K103507 MEDICAL VISORS MV100 Medical Visors, Inc. LNH Class II 2011-02-08
K110199 DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2011-02-08
K101236 VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM GE Healthcare IYN Class II 2011-02-08
K103785 MOBILE MIM Mim Software, Inc. LLZ Class II 2011-02-04
K101312 NUVUE COLORMARK9TM) NEEDLE Nuvue Therapeutics, Inc. IYN Class II 2011-02-04
K100371 SPY INTRA-OPERATIVE IMAGING SYSTEM Novadaq Technologies, Inc. IZI Class II 2011-02-04
K101398 STEREOS WORKSTATION Biospace Med LLZ Class II 2011-02-04
K101842 ACIES Konica Minolta Medical & Graphic, Inc. LLZ Class II 2011-02-04
K103629 PET-512MC TRANSESOPHAGEAL TRANSDUCER Toshiba America Medical Systems, In.C ITX Class II 2011-02-02
K103506 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) Imris, Inc. MOS Class II 2011-02-02
K103385 SECURVIEW DX DIAGNOSTIC WORKSTATION Hologic, Inc. LLZ Class II 2011-02-02
K110071 COR ANALYZER Rcadia Medical Imaging , Ltd. LLZ Class II 2011-01-31
K103465 SYNAPSE 3D CARDIAC TOOLS Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2011-01-31
K103677 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2011-01-31
K110077 NEUCOLONCARE Neusoft Medical Systems Co., Ltd. LLZ Class II 2011-01-28
K103522 SEDECAL Sedecal., Sa. IZL Class II 2011-01-26
K110040 OMNIVISION Modern Module, Inc. LLZ Class II 2011-01-26
K103815 Q-STATION Philips Ultrasound, Inc. LLZ Class II 2011-01-25
K103616 PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER Aktina Medical Physics Corp. IYE Class II 2011-01-25
K102123 VIZION DR Viztek, Inc. KPR Class II 2011-01-24
K100625 REALEYE MODEL VCPS Navotek Medical, Ltd. IYE Class II 2011-01-21
K102153 MOBIUS ULTRASOUND IMAGING SYSTEM Mobisante, Inc. IYO Class II 2011-01-20
K110020 TERASON T3200 ULTRASOUND SYSTEM Teratech Corp. ITX Class II 2011-01-20
K103710 WBR XPRESS PET Ultraspect , Ltd. KPS Class II 2011-01-19
K103182 TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Genoray Co., Ltd. LLZ Class II 2011-01-14
K103394 BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) Varian Medical Systems, Oncology Systems IYE Class II 2011-01-12
K103645 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM Toshiba Medical Systems Corporation, Japan ITX Class II 2011-01-12
K103144 DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER Shantou Institute of Ultrasonic Instruments (Siui IYN Class II 2011-01-12
K102915 VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM Viewray, Incorporated MUJ Class II 2011-01-12
K103365 DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A Ge Healthcare Coils (Usa Instruments, Inc.) MOS Class II 2011-01-12
K103275 SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS Siemens Medical Solutions USA, Inc. MOS Class II 2011-01-11
K103152 6250 ULTRASOUND SYTEMS Esaote, S.p.A. IYN Class II 2011-01-07
K103512 AFFIRM BREAST BIOPSY GUIDANCE SYSTEM Hologic, Inc. IZH Class II 2011-01-07
K102683 THE ADDITION Ob The-Addition, LLC MUI Class II 2011-01-06
K103722 THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. ITX Class II 2011-01-05
K103475 SPINEANALYER MODEL SAPOC Optasia Medical LLZ Class II 2011-01-05
K103149 1.5T 16-CHANNEL HAND-WRIST COIL Invivo Corporation MOS Class II 2011-01-03
K103597 DX-D 100 Agfa Healthcare N.V. IZL Class II 2011-01-03
K103319 I-SEED Theragenics Corp. KXK Class II 2011-01-03
K102285 KRYSTALRAD (ATAL8) Medicatech USA KPR Class II 2011-01-03
K102284 KRYSTALRAD 560 (FLAATZ 560) Medicatech USA KPR Class II 2011-01-03
K101294 PT2 VARIAN PROTON THERAPY SYSTEM Varian Medical Systems, Oncology Systems LHN Class II 2010-12-27
K103193 DOSEVIEW 3D Standard Imaging, Inc. IYE Class II 2010-12-27
K103583 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2010-12-27
K103608 I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND Ellex, Inc. IYO Class II 2010-12-27
K102408 DIGITAL DIAGNOSTIC X-RAY SYSTEM DRGEM Corporation KPR Class II 2010-12-27
K103342 3.0T METAFLEXCOIL Neocoil, LLC MOS Class II 2010-12-23
K102348 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T Rapid Biomedical GmbH MOS Class II 2010-12-22
K102027 AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM Quantel Medical S.A. IYO Class II 2010-12-22
K100703 STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS Comed Co., Ltd. MQB Class II 2010-12-21
K103093 LEKSELL GAMMAPLAN Elekta Instrument AB MUJ Class II 2010-12-21
K102997 SONIXTABLET ULTRASOUND SCANNER Ultrasonix Medical Corporation IYN Class II 2010-12-21

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