meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
27
Latest Decision
2006-11-03

Clearances · page 76 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060421 SONARA; SONARA/TEK Viasys Healthcare, Inc. IYN Class II 2006-11-03
K062454 MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES Siemens Medi Cal Solutions, Inc. LNH Class II 2006-11-03
K063006 GE LOGIQ WORKS General Electric Co. LLZ Class II 2006-11-02
K063029 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 E-Z-Em, Inc. JAK Class II 2006-11-02
K063039 XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM Imaging Dynamics Company , Ltd. MQB Class II 2006-11-02
K063130 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 Toshibamedical Systems Corporation IYN Class II 2006-11-02
K063031 PRISM VIEW, MODEL Kyron Clinical Imaging, Inc. LLZ Class II 2006-11-02
K062598 IMT.LAB SOFTWARE Esaote Europe B.V. LLZ Class II 2006-10-31
K062472 OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 Source-Ray, Inc. IZL Class II 2006-10-31
K062743 UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 Electronic Business Machine Co., Ltd. (Ebm) LLZ Class II 2006-10-31
K062967 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. MUJ Class II 2006-10-30
K062490 VISAGE PACS/CS, RELEASE VERSION 4.1 Mercury Computer Systems, Inc. LLZ Class II 2006-10-27
K061153 GYNESONICS EC6 TRANSDUCER Gynesonics, Inc. ITX Class II 2006-10-27
K062376 DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI Rf Systems Lab. MQB Class II 2006-10-27
K062477 AMICAS VISION SERIES PACS, MODEL 4.3 Amicas, Inc. LLZ Class II 2006-10-27
K063107 3DNET SUITE Biotronics3D, Ltd. LLZ Class II 2006-10-27
K062860 MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A Neusoft Medical Systems Co., Ltd. LNH Class II 2006-10-27
K060836 VISTADENT OC - VERSION 4 Dentsply Intl., Inc. LLZ Class II 2006-10-27
K062830 BIOLUCENT APPLICATOR KIT Biolucent, Inc. JAQ Class II 2006-10-20
K062450 D-SPECT CARDIAC SCANNER SYSTEM Spectrum Dynamics , Ltd. KPS Class II 2006-10-20
K062647 E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 Omega Medical Imaging, Inc. OWB Class II 2006-10-20
K063877 SYNGO LUNG CAD Siemens Medical Solutions USA, Inc. OEB Class II 2006-10-18
K063037 CENTARISONE RIS/PACS Centarisone, LLC LLZ Class II 2006-10-18
K062742 CR 85-X Agfa Corporation MQB Class II 2006-10-13
K062767 CTL-63 AND CTL-128 SPINE ARRAY COILS Invivo Corporation MOS Class II 2006-10-13
K062054 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 Eizo Nanao Corporation LLZ Class II 2006-10-06
K062634 ORTHOXP Imaging Dynamics Company , Ltd. KPR Class II 2006-10-06
K062032 ACCUSOFT, ACCUSOFT XL Direx Systems Corp. MUJ Class II 2006-10-05
K062351 SYNGO DUAL ENERGY Siemens Medical Solutions USA, Inc. JAK Class II 2006-10-05
K062556 ECHELON SHOULDER COIL Hitachi Medical Systems America, Inc. MOS Class II 2006-10-05
K062386 QANGIO CT Medis Medical Imaging Systems BV JAK Class II 2006-10-05
K062360 BRANSIST SAFIRE Shimadzu Corp. IZI Class II 2006-10-05
K062586 XPLORER 1600 PLUS Imaging Dynamics Company , Ltd. MQB Class II 2006-09-29
K062514 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated MUJ Class II 2006-09-28
K062451 NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd. JAK Class II 2006-09-28
K062031 CHASE CARDIAC ANALYSIS SYSTEM Chase Medical, LP LLZ Class II 2006-09-27
K062618 TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT Varian Medical Systems, Inc. IYE Class II 2006-09-22
K062163 MIMVIEWER Mimvista Corp. LLZ Class II 2006-09-22
K062164 RESOLUTIONMD, VERSION 1.3 Calgary Scientific, Inc. LLZ Class II 2006-09-22
K062673 MODIFICATION TO SYNGO INSPACE 4D Siemens AG Medical Solutions JAK Class II 2006-09-22
K062650 EP NAVIGATOR SOFTWARE Philips Medical Systems LLZ Class II 2006-09-21
K062639 MODIFICATION TO HEXAPOD RT COUCH TOP Medical Intelligence Medizintechnik-GmbH-An Elekta JAI Class II 2006-09-21
K062611 IGUIDE SYSTEM Medical Intelligence Medizintechnik-GmbH-An Elekta IYE Class II 2006-09-20
K061871 LEICA MODEL FL800 Leica Microsystems, Inc. IZI Class II 2006-09-20
K062488 IQ-SYSTEM PACS SYSTEM Image Information Systems, Ltd. LLZ Class II 2006-09-19
K061532 GENTLE COLON (REVISION 2.0) Rendoscopy, Inc. LLZ Class II 2006-09-18
K062390 CRYSTALVIEW R200 Alara, Inc. MQB Class II 2006-09-18
K061972 CONNECT IMAGING PACS Connect Imaging, Inc. LLZ Class II 2006-09-18
K062578 DIGI-LITE TCD DEVICE Rimed , Ltd. IYN Class II 2006-09-18
K062417 XPLORER 1100 Imaging Dynamics Company , Ltd. KPR Class II 2006-09-15
K061685 PULSERA Philips Medical Systems North America Co. IZL Class II 2006-09-15
K062335 SEDECAL X PLUS LP PLUS Sedecal., Sa. KPR Class II 2006-09-14
K062141 MAMMOPAD RADIOLUCENT CUSHION Biolucent, Inc. IYX Class I 2006-09-13
K062405 XPLORER 1590 Imaging Dynamics Company , Ltd. KPR Class II 2006-09-13
K062229 CTC WORKSTATION, MODEL 2200 Medical Diagnostic Technologies, Inc. LLZ Class II 2006-09-11
K062039 BIOPSY DIGIT-AM Giotto USA, LLC IZH Class II 2006-09-11
K062062 VOYAGER PACS SYSTEM Voyager Imaging LLZ Class II 2006-09-11
K062315 SUPERDIMENSION/BRONCHUS PREMIUM 2 Superdimension, Ltd. JAK Class II 2006-09-08
K061961 ART LAB SOFTWARE Pie Medical LLZ Class II 2006-09-06
K061995 XCELERA Philips Medical Systems North America Co. LLZ Class II 2006-09-06
K062059 AIE REGION OF INTEREST IMAGE ENHANCEMENT Advanced Image Enhancement LLZ Class II 2006-09-06
K061924 CORONIS 3MP AND MDCG 3120-CB Barcoview LLZ Class II 2006-09-05
K061928 CORONIS COLOR 2MP AND MDCC 2121 Barcoview LLZ Class II 2006-09-05
K061927 CORONIS COLOR 3MP AND MDCC 3120-DL Barcoview LLZ Class II 2006-09-05
K062393 GE VANTAGE PET NEURO SOFTWARE GE Healthcare KPS Class II 2006-09-01
K062223 AGFA MODEL CR30-X Agfa Corporation MQB Class II 2006-09-01
K062298 APOLLO GAMMA CAMERA SYSTEM Adac Laboratories KPS Class II 2006-08-23
K061920 NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER Novarad Corp. LLZ Class II 2006-08-21
K061941 LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 Elekta Instrument AB IWB Class II 2006-08-21
K062328 VITREAACCESS, VERSION 1.0 Vital Images, Inc. LLZ Class II 2006-08-21
K062247 HD11 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2006-08-18
K061873 VERT-X Direx Systems Corp. OXO Class II 2006-08-18
K062107 SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 Hologic, Inc. LLZ Class II 2006-08-18
K061950 HHF1 ECHELON MULTI-PURPOSE COIL Hitachi Medical Systems America, Inc. MOS Class II 2006-08-18
K061926 CORONIS 2MP AND MDCG 2121 - CB Barcoview LLZ Class II 2006-08-18
K061560 SONOMARK Medical Products Manufacturing, Inc. ITX Class II 2006-08-18
K062221 CXDI-40EC Canon, Inc. MQB Class II 2006-08-17
K061595 XAMINER Imaging Dynamics Company , Ltd. KPR Class II 2006-08-17
K061980 SIEMENS ACUSON X500 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2006-08-17
K061354 MICROSELECTRON V3, MODEL 106.990 Nucletron Corporation JAQ Class II 2006-08-17
K061953 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS Ge Oec Medical Systems OWB Class II 2006-08-15
K061999 DRY LASER IMAGER, DRYPRO MODEL 832 Konica Minolta Medical & Graphic, Inc. LMC Class II 2006-08-15
K061361 FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 Faxitron X-Ray Corp. MWP Class II 2006-08-15
K061916 NEURO II-SE, MODELS OR-MB-DR AND OR-DR Imris, Inc. LNH Class II 2006-08-11
K062154 VITAL CONNECT 4.0 Vital Images, Inc. LLZ Class II 2006-08-10
K061855 NEUROQUANT Cortechs Labs, Inc. LLZ Class II 2006-08-10
K061215 VOLCANO S51 FAMILY OF IMAGING SYSTEMS Volcano Corporation IYO Class II 2006-08-10
K061755 MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM Esaote Europe B.V. IYO Class II 2006-08-07
K062053 MONOCHROME LCD MONITOR, RADIFORCE, GS320 Eizo Nanao Corporation LLZ Class II 2006-08-07
K061831 MEDCHANNEL HTS SYSTEM Medchannel, LLC IYN Class II 2006-08-07
K061834 XCAT; XCAT FOR NEURO Xoran Technologies, Inc. JAK Class II 2006-08-07
K061827 SONIX ULTRASOUND SCANNER Ultrasonix Medical Corporation IYN Class II 2006-08-04
K061638 BEST STRAND AND BEST SPACER Best Medical International, Inc. KXK Class II 2006-08-04
K061913 IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A. LHN Class II 2006-07-28
K061952 CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 Invivo MOS Class II 2006-07-28
K061930 INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY Fonar Corp. LNH Class II 2006-07-28
K060906 CALYPSO 4D LOCALIZATION SYSTEM Calypso Medical Technologies, Inc. IYE Class II 2006-07-28
K061561 HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS Hologic, Inc. KGI Class II 2006-07-28
K061241 BIOLUCENT APPLICATOR, MODEL RTA-XX Biolucent, Inc. JAQ Class II 2006-07-28
K061368 DIAGNOSOFT HARP Diagnosoft, Inc. LNH Class II 2006-07-28

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