meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
22
Latest Decision
2013-10-25

Clearances · page 54 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K132188 MAMMOGRAPHY VIEWER SMV658 Fujifilm Medical System U.S.A., Inc. LLZ Class II 2013-10-25
K132804 ACUSON S1000 / S2000 / S3000 Siemens Medical Solutions USA, Inc. Ultrasound Gro IYN Class II 2013-10-24
K132636 DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM Smith & Nephew, Inc. LLZ Class II 2013-10-17
K132438 IMAGENET 5 PC SOFTWARE SYSTEM Topcon Medical Systems, Inc. NFJ Class II 2013-10-17
K132942 SITE-RITE VISION II ULTRASOUND SYSTEM C.R. Bard, Inc. IYN Class II 2013-10-17
K132236 .DECIMAL PROTON APERTURE .Decimal, Inc. IXI Class II 2013-10-16
K132160 VANTAGE TITAN 3T Toshibamedical Systems Corporation LNH Class II 2013-10-16
K131807 HIGH ENERGY LINEAR ACCELERATOR Varian Medical Systems, Inc. IYE Class II 2013-10-11
K130881 ACUSON S2000 AND S3000 Siemens Medical Solutions USA, Inc. IYN Class II 2013-10-11
K132667 SYNERGY ODM Topcon Medical Systems, Inc. NFJ Class II 2013-10-09
K131483 PHILIPS PIXIUM 4343RC Philips Medical Systems Dmc GmbH MQB Class II 2013-10-07
K121447 ISCHEMA VIEW RAPID Ischemaview, Inc. LLZ Class II 2013-10-04
K132861 UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2013-10-04
K132768 S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2013-10-04
K132183 DICOM VIDEO Bar Code Computer, Ltd. LMA Class II 2013-10-03
K131625 ANYSCAN-S SPECT IMAGING SYSTEM Absolute Imaging Solutions KPS Class II 2013-10-03
K122536 AMCAD-UT DETECTION MODEL 2.0 Lin & Associates, LLC LLZ Class II 2013-10-03
K132097 BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY Best Medical International, Inc. JAQ Class II 2013-09-30
K131885 SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) GE Medical Systems SCS MUE Class II 2013-09-26
K132654 ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. Ultrasound Gro IYO Class II 2013-09-26
K132084 PROTURA COUCH SOFTWARE Med-Tec, Inc. D/B/A Civco Medical Solutions JAI Class II 2013-09-26
K132092 ESTEYA Nucletron B.V. JAD Class II 2013-09-26
K131795 NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS Orfit Industries NV IYE Class II 2013-09-26
K131431 AIRO CT SYSTEM Mobius Imaging, LLC JAK Class II 2013-09-26
K131965 XVI R5.0 Elekta Limited IYE Class II 2013-09-25
K131873 NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) MethodSense, Inc. LLZ Class II 2013-09-25
K131891 ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. MUJ Class II 2013-09-25
K132171 AIXPLORER Supersonic Imagine IYN Class II 2013-09-24
K131685 GE ECHOPAC Ge Vingmed Ultrasound AS LLZ Class II 2013-09-24
K131773 BRILLIANCE ICT Philips Healthcare (Cleveland) JAK Class II 2013-09-24
K131937 VOLUSON I/E GE Healthcare IYN Class II 2013-09-24
K132274 AIXPLORER Supersonic Imagine IYN Class II 2013-09-24
K131161 EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, CIVCO Medical Instruments Co., Inc. ITX Class II 2013-09-17
K131114 DIGITAL FLAT PANEL X-RAY DETECTOR Rayence Co., Ltd. MQB Class II 2013-09-17
K131830 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Edan Instruments, Inc. IYO Class II 2013-09-17
K131977 CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT GE Healthcare LLZ Class II 2013-09-17
K132302 QXLINK Vieworks Co., Ltd. LLZ Class II 2013-09-12
K130893 XPERCT REL. 3 Philips Medical Systems Nederland B.V. OWB Class II 2013-09-06
K131389 JUSHA-C31 MEDICAL DISPLAY Nanjing Jusha Display Technology Co., Ltd. LLZ Class II 2013-09-06
K123944 KOSTEC MEDICAL GRADE LDC MONITORS Kostec Co., Ltd. LLZ Class II 2013-09-05
K132610 5MP GRAYSCALE LCD DISPLAY Shenzhen Beacon Display Technology Co., Ltd. LLZ Class II 2013-09-04
K132045 ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS Ge Hungary Kft KPQ Class II 2013-09-04
K131576 OPTIMA CT660 Ge Medical Systems, LLC JAK Class II 2013-08-30
K131241 SWIP Philips Medical Systems Nederland B.V. LNH Class II 2013-08-30
K123540 SYNGO CT PULMO 3D Siemens Medical Systems, Inc. JAK Class II 2013-08-29
K130374 OMNI-VUE 2 SYSTEM Genesis Digital Imaging, Inc. LLZ Class II 2013-08-29
K130242 MAVEN PRO Nsequence LLZ Class II 2013-08-29
K131408 CR 12-X DIGITIZER Agfa Healthcare N.V. MQB Class II 2013-08-29
K131594 EZDENTI-I; E2; PRORA VIEW Ewoosoft Co., Ltd. LLZ Class II 2013-08-29
K131616 EZ3D-I, E3 Ewoosoft Co., Ltd. LLZ Class II 2013-08-29
K132587 MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR Ned Display Solutions , Ltd. LLZ Class II 2013-08-29
K131507 XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM Toshibamedical Systems Corporation IYN Class II 2013-08-28
K131582 SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM Sensus Healthcare JAD Class II 2013-08-28
K131527 LOGIQ S8 GE Healthcare IYN Class II 2013-08-26
K130936 AERODR SYSTEM WITH P-31 Konica Minolta Medical & Graphic, Inc. MQB Class II 2013-08-22
K132304 EPIQ DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2013-08-21
K131391 JUSHA-M32 MEDICAL DISPLAY Nanjing Jusha Display Technology Co., Ltd. LLZ Class II 2013-08-21
K131158 CORVIEW Marrek, Inc. LLZ Class II 2013-08-21
K131862 3DVH Sun Nuclear Corporation IYE Class II 2013-08-21
K132228 UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYO Class II 2013-08-20
K130960 SURESUBTRACTION ORTHO Toshibamedical Systems Corporation JAK Class II 2013-08-20
K131466 MAPCHECK2, ARCCHECK Sun Nuclear Corporation IYE Class II 2013-08-20
K130749 SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR Siemens Medical Solutions USA, Inc. LLZ Class II 2013-08-20
K131634 SYMBIA Siemens Medical Solutions USA, Inc. KPS Class II 2013-08-16
K130779 LVIVO EF SYSTEM Diacardio, Ltd. LLZ Class II 2013-08-15
K131570 ORTHOVISION Ewoosoft Co., Ltd. LLZ Class II 2013-08-15
K132341 DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2013-08-15
K132165 QLAB QUANTIFICATION SOFTWARE Philips Ultrasound, Inc. LLZ Class II 2013-08-09
K131313 ACTIVE BREATHING COORDINATOR Aktina Medical Corp. IYE Class II 2013-08-07
K130743 THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL Ortho Kinematics, Inc. LLZ Class II 2013-08-06
K131704 EPIDOSE Sun Nuclear Corporation IYE Class II 2013-08-05
K131305 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE Chison Medical Imaging Co., Ltd. IYN Class II 2013-08-01
K131150 CURA COMPENSATOR Cura Medical Technologies, LLC IXI Class II 2013-07-30
K131448 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION Koelis LLZ Class II 2013-07-26
K131498 IQQA-LIVER MULTIMODALITY SOFTWARE Edda Technology, Inc. LLZ Class II 2013-07-25
K130706 DUOFLEX COIL SUITE (1.5T) Mr Instruments, Inc. MOS Class II 2013-07-25
K132087 PERCUNAV SYSTEM Philips Health Care JAK Class II 2013-07-24
K131690 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2013-07-24
K131263 XPERGUIDE Philips Medical Systems Nederland B.V. OWB Class II 2013-07-24
K130648 FORUM GLAUCOMA WORKPLACE Carl Zeiss Meditec, AG NFJ Class II 2013-07-23
K132062 ESIE APPS SUITE Siemens Medical Solutions USA, Inc. LLZ Class II 2013-07-23
K131822 ULTRAEXTEND USWS-900A V2.1 AND V3.1 Toshiba America Medical Systems, In.C LLZ Class II 2013-07-23
K130658 ELIXBO PM545 Xbo Medical Systems Co., Ltd. LNH Class II 2013-07-19
K131905 SOLID GEL PAD Bluemtech MUI Class II 2013-07-18
K130224 ICT Imris, Inc. JAK Class II 2013-07-18
K123332 NAOMI-CT Lk Consulting Group OAS Class II 2013-07-18
K131137 21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5) Jvckenwood Corporation LLZ Class II 2013-07-18
K131233 HERMES MEDICAL IMAGING SUITE V5.3 Hermes Medical Solutions AB KPS Class II 2013-07-16
K131428 RADVISION Acoustic Medsystems, Inc. MUJ Class II 2013-07-16
K123599 INGENUITY DIGITAL PET/CT Philips Healthcare (Cleveland) KPS Class II 2013-07-12
K131227 PADSCAN HD SERIES BLADDER SCANNER Carenoso Technology Co., Ltd. IYO Class II 2013-07-12
K131514 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Ge Vingmed Ultrasound AS IYN Class II 2013-07-12
K131424 MIPLATFORM MEDICAL IMAGING SUITE Hinacom Software and Technology, Ltd. LLZ Class II 2013-07-12
K130442 NEWTOM VGI AND NEWTOM 5G Qr S.R.L. OAS Class II 2013-07-03
K131090 2MP COLOR LCD MONITOR, RADIFORCE MX215 Eizo Corporation LLZ Class II 2013-07-03
K131106 DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS, Canon, Inc. MQB Class II 2013-07-03
K130935 DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA Rayence Co., Ltd. MQB Class II 2013-07-02
K130724 CODIAGNOSTIX IMPLANT PLANNING SOFTWARE Straumann USA LLZ Class II 2013-06-28
K130638 ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Philips Medical Systems Nederland B.V. OWB Class II 2013-06-28
K130549 INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR Carl Zeiss Meditec, Inc. JAD Class II 2013-06-26

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