meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2006-04-19

Clearances · page 78 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060052 GE LIGHTSPEED XTRA CT SCANNER SYSTEM Ge Medical Systems, LLC JAK Class II 2006-04-19
K060873 VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS Sentinelle Medical, Inc. MOS Class II 2006-04-14
K060532 HDR 1000 PLUS WELL CHAMBER, MODEL 90008 Standard Imaging, Inc. JAQ Class II 2006-04-11
K060695 IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A. LHN Class II 2006-04-11
K060626 VUMAX Sonomed, Inc. IYO Class II 2006-04-11
K060064 STETHOFLUX Odvi JAF Class II 2006-04-10
K060800 SEEKER/SPARK ULTRASOUND SYSTEM Ardent Sound, Inc. IYO Class II 2006-04-07
K060840 SVIEW Mri Cardiac Services, Incorporated LLZ Class II 2006-04-07
K060314 ROTATING GAMMA SYSTEM. GAMMA ART-6000 American Radiosurgery, Inc. IWB Class II 2006-04-06
K060779 ADVANCE VESSEL ANALYSIS II GE Healthcare JAK Class II 2006-04-05
K060566 MINXRAY, MODELS HFP24 AND HFP40 Mikasa X-Ray Co., Ltd. IZL Class II 2006-04-05
K060749 XPERCT Philips Medical Systems North America Co. IZI Class II 2006-04-04
K052118 DOSE VERIFICATION SYSTEM Sicel Technologies, Inc. LHN Class II 2006-04-03
K060689 1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL Resonance Innovations, LLC MOS Class II 2006-03-31
K060737 SINMED POSITIONING DEVICES Sinmed BV IYE Class II 2006-03-31
K060542 GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX General Electric Co. IYN Class II 2006-03-31
K060550 KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 Eastman Kodak Company KPR Class II 2006-03-31
K052424 MAXILIM Medicim NV LLZ Class II 2006-03-31
K051753 ACCU-SOURCE Oncology Systems, Inc. JAQ Class II 2006-03-29
K060505 VOXAR 3D ENTERPRISE, MODEL 6.1 Barcoview Mis Edinburgh LLZ Class II 2006-03-29
K052383 INNOCURE IMRT FILTER (COMPENSATORS) Innocure, LLC IXI Class II 2006-03-29
K060344 O-ARM IMAGING SYSTEM Breakaway Imaging, LLC OXO Class II 2006-03-29
K060547 ACCESS BREAST COIL 4/SMS Confirma, Inc. MOS Class II 2006-03-29
K060486 CYCLONE, MODEL MAICAM 180 Spectrica KPS Class II 2006-03-23
K060451 M-VU VIEWER STATION Vucomp, Inc. LLZ Class II 2006-03-22
K060267 VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE Implant Logic Systems, Ltd. LLZ Class II 2006-03-17
K060631 BIOGRAPH 64 AND BIOGRAPH 40 Siemens Medical Solutions USA, Inc. KPS Class II 2006-03-17
K060137 KODAK ECLIPSE IMAGE PROCESSING SOFTWARE Eastman Kodak Company MQB Class II 2006-03-16
K060440 CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER Codonics, Inc. LMC Class II 2006-03-16
K060226 ONCOR EXPRESSION Siemens Medical Solutions USA, Inc. IYE Class II 2006-03-15
K060263 IQPACS S.C. Info World S.R.L. LLZ Class II 2006-03-15
K060401 MEDRAD 3.0T ECOIL IMAGING SYSTEM Medrad, Inc. MOS Class II 2006-03-15
K052212 MIGUE Direx Systems Corp. IYE Class II 2006-03-10
K052839 CT PERFUSION 4 GE Healthcare JAK Class II 2006-03-10
K060349 PROGUIDE NEEDLE SET Nucletron Corporation JAQ Class II 2006-03-10
K060433 DIGITAL RADIOGRAPHY CXDI-50C Canon, Inc. MQB Class II 2006-03-10
K060453 AZE VIRTUALPLACE Aze, Ltd. LLZ Class II 2006-03-09
K060378 VITREA2 VERSION 3.8.1 Vital Images, Inc. LLZ Class II 2006-03-09
K060035 MDXNET Cybermdx, Inc. LLZ Class II 2006-03-09
K053280 PROBEAT Hitachi, Ltd., Power Systems Group LHN Class II 2006-03-09
K053485 THERATRON EQUINOX, MODELS 80 CM AND 100 CM Mds Nordion, Inc. IWB Class II 2006-03-09
K052202 AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc. OWB Class II 2006-03-07
K053463 AIM ACCURACY IN MARKING SYSTEM Georgene Austria ITX Class II 2006-03-07
K053039 CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF Clinton Electronics Corp. LLZ Class II 2006-03-01
K053595 CURAY CUSTOM SEED ARRAY Biolucent, Inc. KXK Class II 2006-02-28
K060259 DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 Ge Medical Systems, LLC OWB Class II 2006-02-22
K052705 DART-12 Direx Systems Corp. IYE Class II 2006-02-21
K053148 CXR16 Hitachi Medical Systems America, Inc. JAK Class II 2006-02-17
K053183 JIVE X SOFTWARE Visus Technology Transfer GmbH LLZ Class II 2006-02-16
K060210 MEDIPORT Maxant Technologies, Inc. LLZ Class II 2006-02-10
K053592 SIMPLANT DR. JAMES Materialise NV LLZ Class II 2006-02-08
K060055 KODAK PACS Eastman Kodak Company LLZ Class II 2006-02-07
K060060 BIOGRAPH 6 Siemens Medical Solutions USA, Inc. KPS Class II 2006-02-03
K053301 CEDARA I-RESPONSE CEDARA PET/CT Cedara Software Corp. LLZ Class II 2006-02-03
K053500 FRAMELESS RADIOSURGERY COMPONENTS Brainlab AG IYE Class II 2006-02-03
K060136 PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR Planar Systems, Inc. LLZ Class II 2006-01-31
K053086 MIE - GAMMA CAMERA SYSTEMS Mie America, Inc. KPS Class II 2006-01-27
K053455 ENCOMPASS.NET Empiric Systems, LLC LLZ Class II 2006-01-25
K053309 ALTAIRE INTERVENTIONAL MR PACKAGE Hitachi Medical Systems America, Inc. LNH Class II 2006-01-24
K053641 IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A. LHN Class II 2006-01-24
K053648 PIONEER TC8080, COMPANION III Viasys Neuro Care IYN Class II 2006-01-24
K060087 ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2006-01-24
K060020 AUTOQUANT PLUS Adac Laboratories KPS Class II 2006-01-20
K060003 EXCELART VANTAGE ZGV Toshibamedical Systems Corporation LNH Class II 2006-01-18
K053634 COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION Agfa Corporation MQB Class II 2006-01-17
K060059 ALOKA SD-3500 ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2006-01-13
K052423 MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION Siemens Medi Cal Solutions, Inc. LNH Class II 2006-01-13
K052920 DELTA4 Scandidos AB IYE Class II 2006-01-12
K053062 CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 Cardiarc , Ltd. KPS Class II 2006-01-06
K053029 NDR+/DIVA-D Nical Spa MQB Class II 2006-01-06
K052682 ALIGNRT Vision RT Limited IYE Class II 2006-01-06
K053210 MAYFIELD SCANMATE MOBILE CT SYSTEM Schaerer Mayfield USA, Inc. JAK Class II 2006-01-06
K053347 KODAK CARESTREAM PACS Eastman Kodak Company LLZ Class II 2006-01-04
K053530 SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2006-01-03
K052988 CAAS Pie Medical Imaging BV LLZ Class II 2005-12-30
K052587 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF J. Morita USA, Inc. JAK Class II 2005-12-27
K052942 21.3INCH MONOCHROME LCD MONITOR Nec-Mitsubishi Electric Visual Systems Corp. LLZ Class II 2005-12-27
K053279 UROVANTAGE Pck Electronic Industry & Trade Co., Ltd. OWB Class II 2005-12-22
K053458 WEB1000 Agfa Corp. LLZ Class II 2005-12-22
K050843 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM Xoft, Inc. JAD Class II 2005-12-22
K052467 BRAIN VIEWRX VIEWER, VERSION 1.0 Kyron Clinical Imaging, Inc. LLZ Class II 2005-12-20
K052120 LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 Heeyoung Co., Ltd. LLZ Class II 2005-12-16
K053435 GE VOLUSON I General Electric Co. IYN Class II 2005-12-16
K053154 MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM Pie Medical IYN Class II 2005-12-16
K052943 DDRFORMULA AND DDRFORMULA PLUS Swissray Medical AG KPR Class II 2005-12-15
K053173 DS CASSETTE Konica Minolta Medical & Graphic, Inc. IXA Class II 2005-12-15
K052632 VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE Vital Images, Inc. LLZ Class II 2005-12-15
K053258 EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Corp. IYN Class II 2005-12-09
K053346 MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2005-12-09
K053162 DEXTROSCOPE & DEXTROBEAM Volume Interactions Pte, Ltd. LLZ Class II 2005-12-09
K052023 CADIMAS VERSION 1.0 Alan Penn & Associates., Inc. LNH Class II 2005-12-08
K053281 EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) Emageon, Inc. LLZ Class II 2005-12-07
K053325 MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 Mediwatch, Ltd. IYO Class II 2005-12-07
K052963 MEDIQ VERSION 1.0 Clario Medical Imaging, Inc. LLZ Class II 2005-12-05
K053133 SYNGO DYNAMICS, VERSION 5.0 Siemens Medical Solutions USA, Inc. LLZ Class II 2005-12-05
K052348 IN VISION GOLD WITH SPIN VISION, MODEL 891 SV Volcano Corporation IYO Class II 2005-12-02
K052610 IMAGE STAR II Lakeshore Technologies, Inc. JAA Class II 2005-11-30
K052391 VISION (WITH OFF-LINE REVIEW) Varian Medical Systems IYE Class II 2005-11-23
K052894 SONOLINE G60 S ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2005-11-23
K053155 VIMPLANT Cybermed, Inc. LLZ Class II 2005-11-23

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