meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
2009-09-22

Clearances · page 67 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K092083 EXTEND FRAME SYSTEM, MODEL 1009633 Elekta Instrument AB IWB Class II 2009-09-22
K092742 NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd. JAK Class II 2009-09-22
K090773 CFI ULTRASOUND PROBE DRAPE Contour Fabricators, Inc. IYO Class II 2009-09-18
K092145 160MLC OPTION Siemens Medical Solutions USA, Inc. IYE Class II 2009-09-18
K092067 ABVS WORKPLACE Siemens AG Medical Solutions LLZ Class II 2009-09-18
K092653 VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 Medcom GmbH LHN Class II 2009-09-18
K090742 DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A Samsung Mobile Display Co., Ltd. MQB Class II 2009-09-18
K091999 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. IYE Class II 2009-09-18
K092018 OMNIPRO INCLINE Iba Dosimetry GmbH IYE Class II 2009-09-18
K091117 ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA Isoaid, LLC KXK Class II 2009-09-15
K092019 MODEL 1014 PC ELECTROMETER Sun Nuclear Corp. IYE Class II 2009-09-15
K092134 STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) Statrad, LLC LLZ Class II 2009-09-15
K092237 NSM-S15 SYSTEM Neusoft Medical Systems Co., Ltd. LNH Class II 2009-09-09
K092365 INREACH SYSTEM, MODEL AAS00161-02 Superdimension, Ltd. JAK Class II 2009-09-04
K091877 CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL Chison Medical Imaging Co., Ltd. ITX Class II 2009-09-02
K091166 IMRX Imris, Inc. LNH Class II 2009-09-02
K092285 PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 Best Medical Canada , Ltd. IYE Class II 2009-08-28
K092458 PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 Isoray Medical, Inc. KXK Class II 2009-08-28
K092405 MAMMOSITE MULTI LUMEN Hologic, Inc. JAQ Class II 2009-08-27
K092519 SYNGO.X Siemens AG Medical Solutions LLZ Class II 2009-08-27
K090811 INSPIRA HD, MODEL: NL1000 Neurologica Corporation KPS Class II 2009-08-27
K092307 IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR Imasight, Inc. KPR Class II 2009-08-25
K092004 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ GE Healthcare OWB Class II 2009-08-25
K092102 NORDICBRAINEX SOFTWARE, VERSION 1.0 Nordicimaginglab AS LLZ Class II 2009-08-25
K091628 OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX Protec GmbH & Co. KG IXW Class II 2009-08-21
K092140 GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND Ge Medical Systems Israel, Ultrasound, Ltd. IYO Class II 2009-08-21
K091902 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 Invivo MOS Class II 2009-08-21
K092323 CONTURA CAVITY MAINTENANCE CATHETER Senorx, Inc. JAQ Class II 2009-08-19
K091288 MEDI-6000 MEDICAL IMAGE DIGITIZER Microtek International, Inc. LMA Class II 2009-08-14
K091970 AIXPLORER ULTRASOUND SYSTEM Supersonic Imagine IYN Class II 2009-08-12
K091230 HDR PROSTATE TEMPLATE AND ACCESSORIES Photon Technologies Corporation JAQ Class II 2009-08-12
K083728 INVISION SYSTEM Inneroptic Technology, Inc. IYO Class II 2009-08-12
K091629 PROTEUS 235 PROTON THERAPY SYSTEM Ion Beam Applications S.A. LHN Class II 2009-08-11
K092238 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS Agfa Healthcare N.V. MQB Class II 2009-08-11
K092136 PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 Isoray Medical, Inc. KXK Class II 2009-08-07
K092235 BEYONDIMAGE WORKSTATION Neusoft Medical Systems Co., Ltd. LLZ Class II 2009-08-06
K092079 MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND Ge Medical Systems Israel, Ultrasound, Ltd. IYN Class II 2009-08-06
K091403 MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY Oncology Tech, LLC IXI Class II 2009-07-29
K092179 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 Toshiba America Medical Systems, In.C IYN Class II 2009-07-29
K092159 ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2009-07-28
K083421 MR-TOUCH OPTION Ge Medical Systems, LLC LNH Class II 2009-07-24
K091580 PICA WHOLE BODY MRI SYSTEM Time Medical Limited LNH Class II 2009-07-24
K091911 BOLUS COMPENSATOR .Decimal, Inc. IXI Class II 2009-07-21
K092081 QXLINK Vieworks Co., Ltd. LLZ Class II 2009-07-21
K091645 GOLD ANCHOR Naslund Medical AB IYE Class II 2009-07-21
K091444 PERFSCAPE Olea Medical LNH Class II 2009-07-20
K090972 LEKSELL GAMMAPLAN Elekta Instrument AB MUJ Class II 2009-07-20
K091889 DRX-EVOLUTION, MODEL VX3733-SYS Carestream Health, Inc. KPR Class II 2009-07-20
K091536 OPTIMA MR450W Ge Medical Systems, LLC LNH Class II 2009-07-17
K091558 BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM Bioptics, Inc. MWP Class II 2009-07-17
K092013 SYNGO VOLUME PERFUSION-CT BODY Siemens AG Medical Solutions JAK Class II 2009-07-17
K091804 CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS Philips Ultrasound, Inc. ITX Class II 2009-07-17
K091179 MONACO RTP SYSTEM, VMAT OPTION Computerized Medical Systems, Inc. MUJ Class II 2009-07-16
K090914 AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E Xoft, Inc. JAD Class II 2009-07-16
K090893 TIGRT TPS Linatech, LLC MUJ Class II 2009-07-15
K091274 CORONIS 5MP HD, MODEL MDMG 5121 Barco N.V. LLZ Class II 2009-07-14
K091517 RALCO, MODEL R225 ACS Ralco S.R.L. IZW Class II 2009-07-14
K090655 PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 Source-Ray, Inc. IZL Class II 2009-07-14
K091941 DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ITX Class II 2009-07-09
K090802 TIGRT MLC, TIGRT DMLC Linatech, LLC IYE Class II 2009-07-07
K083658 PACS PLUS 5TH EDITION Medical Standard Co., Ltd. LLZ Class II 2009-07-07
K091687 PACSMATE, MODEL MMD-4300C/MMD-4300CX Iei Technology Corp. LLZ Class II 2009-07-07
K091378 MAMMOSITE II RADIATION THERAPY SYSTEM Hologic, Inc. JAQ Class II 2009-07-02
K091747 FLAATZ 500 Drtech Corp. KPR Class II 2009-07-01
K082450 IDR Icrco, Inc. MQB Class II 2009-06-30
K090268 SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION Shimadzu Corp. IZL Class II 2009-06-30
K091598 LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS Nucletron Corp. JAQ Class II 2009-06-29
K091262 MR CARDIAC FUNCTION ANALYSIS Ziosoft, Inc. LLZ Class II 2009-06-29
K091325 TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS Cooper Surgical KGI Class II 2009-06-29
K091658 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 GE Healthcare OWB Class II 2009-06-29
K083640 DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D Choong Wae Medical Corp. KPR Class II 2009-06-29
K091001 MYRIAN 1.4 Intrasense LLZ Class II 2009-06-29
K091546 NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 Noras Mri Products GmbH MOS Class II 2009-06-24
K091673 GE LIGHTSPEED ACT FP16 Ge Medical Systems, Inc. JAK Class II 2009-06-24
K090417 AXXENT FLEXISHIELD MINI Xoft, Inc. IXI Class II 2009-06-23
K083520 INTELEPACS, MODEL VERSION 3.X.X Intelerad Medical Systems Incorporated LLZ Class II 2009-06-23
K090668 VISION TOOLS Millensys LLZ Class II 2009-06-23
K091209 PORTALVISION ADVANCED IMAGING Varian Medical Systems, Inc. IYE Class II 2009-06-23
K090462 BRILLIANCE DUAL ENERGY OPTION Philips Medical Systems (Cleveland), Inc. JAK Class II 2009-06-23
K090431 DEXIS SOFTWARE Dexis, LLC LLZ Class II 2009-06-22
K091032 CERNER PROVISION WORKSTATION (VERSION 2.5) Cerner Corp. LLZ Class II 2009-06-22
K091680 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Edan Instruments, Inc. ITX Class II 2009-06-19
K091602 MUCHECK V8 Oncology Data Systems, Inc. IYE Class II 2009-06-18
K091518 CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM Mcube Technology Co., Ltd. IYO Class II 2009-06-18
K091492 MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. MUJ Class II 2009-06-18
K090745 ARTIS ZEE / ZEEGOS WITH SW VC14 Siemens Medical Solutions USA, Inc. IZI Class II 2009-06-18
K091669 OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III Xioao Mdt Technology Co, Ltd. LNH Class II 2009-06-18
K091132 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems IYE Class II 2009-06-17
K091103 GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS Hitachi Medical Systems America, Inc. JAK Class II 2009-06-15
K091545 DIGITAL RADIOGRAPHY CXDI-60C Canon, Inc. MQB Class II 2009-06-15
K090706 ONCENTRA SIMULATION 2.3 Nucletron Corporation KPQ Class II 2009-06-15
K090546 MODIFICATION TO NORDICICE SOFTWARE Nordicimaginglab AS LLZ Class II 2009-06-08
K091498 VITREA ENDOVASCULAR STENT PLANNING SOFTWARE Vital Images, Inc. LLZ Class II 2009-06-05
K091368 R2 DIGITALNOW HD(DIGITALNOW HD) Hologic, Inc. LLZ Class II 2009-06-04
K083917 X-RAY, TOMOGRAPHY, COMPUTED, DENTAL Suni Medical Imaging, Inc. OAS Class II 2009-06-02
K091435 DIGITAL RADIOGRAPHY MODEL CXDI-55G Canon, Inc. MQB Class II 2009-05-29
K091436 DIGITAL RADIOGRAPHY, MODEL CXDI-55C Canon, Inc. MQB Class II 2009-05-29
K091195 PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 Philips Medical Systems (Cleveland), Inc. JAK Class II 2009-05-27
K091145 FLEXIPLAN 3D AND 3D+ Isodose Control B.V. MUJ Class II 2009-05-27
K090531 RADCALC SOFTWARE, VERSION 6.0 Lifeline Software, Inc. MUJ Class II 2009-05-27

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