meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2007-03-05

Clearances · page 75 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K063512 LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB IWB Class II 2007-03-05
K070077 ULTRASOUND SCANNER PROFOCUS, MODEL 2202 B-K Medical Aps IYO Class II 2007-03-05
K070089 SYNTERMED LIVE Syntermed, Inc. LLZ Class II 2007-03-02
K063815 VARIAN ESOPHAGUS BOUGIE APPLICATOR Varian Medical Systems JAQ Class II 2007-03-01
K062214 BRACHYSCIENCES STRANDPORT Worldwide Medical Technologies, LLC KXK Class II 2007-03-01
K070248 VELOCITYAIS Velocity Medical Solutions, LLC LLZ Class II 2007-03-01
K070322 SYNGO DYNAMICS, VERSION 6.0 Siemens Medical Solutions USA, Inc. LLZ Class II 2007-02-27
K070131 RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS Eizo Nanao Corporation LLZ Class II 2007-02-15
K070244 AEGIS Sentinelle Medical, Inc. LLZ Class II 2007-02-09
K070094 TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM Varian Medical Systems, Inc. IYE Class II 2007-02-09
K070122 MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320 Eizo Nanao Corporation LLZ Class II 2007-02-08
K063839 POSITIONER C-Rad Positioning AB IYE Class II 2007-02-08
K063622 FINECUBE DENTAL CT The Yoshida Dental Mfg. Co., Ltd. OAS Class II 2007-02-08
K063683 OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE Olympus Medical Systems Corporation IYN Class II 2007-02-08
K063691 NEUTRON THERAPY SYSTEM Northern Illinois Univ. Outreach IWL Class II 2007-01-31
K063730 DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0 Volume Interactions Pte, Ltd. LLZ Class II 2007-01-31
K070079 X3C DIGITAL RADIOGRAPHIC DETECTOR Imaging Dynamics Company , Ltd. MQB Class II 2007-01-31
K063472 ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 Meda , Ltd. IYO Class II 2007-01-31
K063773 VOLUMETRIC TOMOGRAPHY Instrumentarium Dental, Inc. OAS Class II 2007-01-31
K063433 ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 Meda , Ltd. IYO Class II 2007-01-29
K063846 EIGEN DSA 2000 Eigen LLZ Class II 2007-01-26
K070080 INTELEPACS Intelerad Medical Systems, Inc. LLZ Class II 2007-01-24
K063294 TOPACS Radiological Specialists, Inc. LLZ Class II 2007-01-24
K063548 COR ANALYZER 1, VERSION 1.4 Rcadia Medical Imaging , Ltd. LLZ Class II 2007-01-22
K063439 MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS Mtd, Inc. LLZ Class II 2007-01-22
K063539 NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1 Nordicicemedical AS LLZ Class II 2007-01-17
K063826 SYNGO MI APPLICATIONS 2007A Siemens Medical Solutions USA, Inc. LLZ Class II 2007-01-12
K063345 SPY IMAGING SYSTEM Novadaq Technologies, Inc. IZI Class II 2007-01-12
K063456 SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM Topex, Inc. JAD Class II 2007-01-09
K063781 PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE Philips Medical Systems North America Co. LLZ Class II 2007-01-05
K063762 SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY Siemens AG Medical Solutions JAK Class II 2007-01-05
K063803 ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI IYN Class II 2007-01-05
K063470 AYCAN WORKSTATION OSIRIX Aycan Digitalsysteme GmbH LLZ Class II 2007-01-05
K063559 ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5 Philips Medical Systems LNH Class II 2007-01-04
K063761 ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2007-01-04
K062905 NIO FUSION 4MP; MDNC 4130 Barcoview LLZ Class II 2006-12-29
K062788 COLLIMATOR, MODEL M-38 Umi International KPW Class II 2006-12-28
K063262 AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS Virtual Imaging IZL Class II 2006-12-26
K063628 CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY Ge Healthcare Integrated IT Solutions LLZ Class II 2006-12-26
K063382 HDR CT COMPATIBLE SPLIT RING APPLICATOR Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2006-12-26
K063381 CT COMPATIBLE F/S/D APPLICATORS Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2006-12-22
K063493 I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 Boston Scientific Corp IYN Class II 2006-12-21
K063424 FILM DIGITZER, MODEL 2908 MAMMO PRO Array Corp. LMA Class II 2006-12-21
K063518 HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. IYN Class II 2006-12-21
K063230 INTEGRA RADIONICS IMAGEFUSION 3 Integra Radionics, Inc. MUJ Class II 2006-12-21
K063600 VISTA AVS Summit Doppler Systems, Inc. JAF Class II 2006-12-19
K063270 RPM RESPIRATORY GATING SYSTEM Varian Medical Systems, Inc. IYE Class II 2006-12-14
K063482 CROSSPLAN / ACCUSOFT-XL V.4.04 Direx Systems Corp. MUJ Class II 2006-12-14
K063579 2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC Chi Lin Technology Co., Ltd. LLZ Class II 2006-12-14
K063580 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2006-12-14
K062891 PROTON THERAPY SYSTEM Indiana University Cyclotron Facility LHN Class II 2006-12-14
K063274 ACCULOC BREAST LOCALIZATION SYSTEM Northwest Medical Physics Equipment, Inc. IYE Class II 2006-12-12
K063392 IMCO-STAT Imco Technologies LLZ Class II 2006-12-12
K063513 ECHELON MR-RCC-150 CARDIAC COIL Hitachi Medical Systems America, Inc. MOS Class II 2006-12-12
K063253 RCHIVE PACS Sobha Renaissance Information Technology Pvt, Ltd. LLZ Class II 2006-12-12
K063337 OPAL-RAD Viztek, Inc. LLZ Class II 2006-12-12
K063221 MEDWEB ADVANCED 3D WEB PACS Nexsys Electronics, Inc. LLZ Class II 2006-12-12
K063505 VISUALASE ENVISION SOFTWARE SYSTEM Biotex, Inc. LLZ Class II 2006-12-12
K063153 NOVAPACS Novarad Corp. LLZ Class II 2006-12-07
K063200 20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204) Totoku Electric Co., Ltd. LLZ Class II 2006-12-07
K063500 DC-6 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2006-12-06
K063199 21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2) Totoku Electric Co., Ltd. LLZ Class II 2006-12-04
K063188 DEL-IMS Del Medical Imaging Corp. LLZ Class II 2006-11-30
K063198 21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2) Totoku Electric Co., Ltd. LLZ Class II 2006-11-30
K063507 SYNGO NEURO PBV CT Siemens AG JAK Class II 2006-11-30
K063197 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) Totoku Electric Co., Ltd. LLZ Class II 2006-11-30
K063342 MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS Medrad, Inc. MOS Class II 2006-11-30
K063177 RAPID STRAND RX Oncura, Inc. KXK Class II 2006-11-30
K063344 CAAS QCA 3D Pie Medical Imaging BV LLZ Class II 2006-11-28
K063138 MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2006-11-22
K063421 DX-SI Agfa Corp. MQB Class II 2006-11-22
K061608 MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Corp. IYN Class II 2006-11-22
K063327 ORTHOVIEW Merdian Technique, Ltd. LLZ Class II 2006-11-22
K063021 PROFILER 2 Sun Nuclear Corp. IYE Class II 2006-11-22
K062817 PTW DAVID IMRT QC VERIFICATION SYSTEM Ptw-New York Corp. IYE Class II 2006-11-22
K063247 XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND Imaging Dynamics Company , Ltd. KPR Class II 2006-11-22
K063246 XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND Imaging Dynamics Company , Ltd. KPR Class II 2006-11-22
K062985 IVUS ENHANCER Indec Systems, Inc. LLZ Class II 2006-11-22
K062781 MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY Symtium Corporation IXI Class II 2006-11-21
K062571 LONGPORT EPISCAN, MODEL-I-200 Longport, Inc. IYO Class II 2006-11-21
K063361 EXCELART VANTAGE ATLAS, MODEL MRT-1503 Toshiba America Medical Systems, In.C LNH Class II 2006-11-21
K062237 CADI, VERSION 4 Synca Marketing, Inc. LLZ Class II 2006-11-20
K063373 FLEX LOOP COIL SET 3T Siemens AG MOS Class II 2006-11-17
K063283 DEFINIUM 5000 X-RAY SYSTEM Sedecal., Sa. MQB Class II 2006-11-17
K062131 NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB Barcoview LLZ Class II 2006-11-17
K063289 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC Chi Lin Technology Co., Ltd. LLZ Class II 2006-11-16
K063085 MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYO Class II 2006-11-14
K061696 IQQA-LIVER SOFTWARE Edda Technology, Inc. LLZ Class II 2006-11-13
K063207 S-SCAN MRI SYSTEM Esaote, S.p.A. LNH Class II 2006-11-09
K063241 CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION Toshiba America Medical Systems, In.C JAK Class II 2006-11-09
K062241 ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR North American Scientific, Inc. JAQ Class II 2006-11-09
K063120 COLOR LCD MONITOR, RADIFORCE, MODEL RX210 Eizo Nanao Corporation LLZ Class II 2006-11-09
K063266 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC Chi Lin Technology Co., Ltd. LLZ Class II 2006-11-09
K063267 ISITE PACS, V 4. X Stentor Inc., A Philips Medical Systems Co. LLZ Class II 2006-11-09
K062384 CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE Isoray, Inc. KXK Class II 2006-11-09
K063093 SECTRA WORKSTATION, VERSION 11.1 Sectra Imtec AB LLZ Class II 2006-11-07
K062757 XERON PACS Xeron Healthcare Corp. LLZ Class II 2006-11-07
K062135 ART SHIELDED BREAST APPLICATOR Advanced Radiation Therapy, LLC JAQ Class II 2006-11-07
K063184 MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION Toshiba America Medical Systems, In.C JAK Class II 2006-11-03
K063189 TSX-301A, AQUILION ONE CT SYSTEM Toshiba America Medical Systems, In.C JAK Class II 2006-11-03

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