meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
21
Latest Decision
2005-08-17

Clearances · page 80 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051901 NIO 3MP-21 Barcoview LLZ Class II 2005-08-17
K052021 V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER Siemens Medical Solutions USA, Inc. ITX Class II 2005-08-17
K052077 G-SCAN CERVICAL SPINE COIL Esaote, S.p.A. MOS Class II 2005-08-16
K051813 ULTRAPACS Ultrarad Corporation LLZ Class II 2005-08-15
K051840 ENSITE VERISMO SOFTWARE St Jude Medical LLZ Class II 2005-08-15
K050320 FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT Ascendia Medtech AB ITX Class II 2005-08-15
K051809 EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM Medical Insight A/S LLZ Class II 2005-08-15
K051932 ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 Elekta, Inc. IYE Class II 2005-08-12
K052109 SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) Sonosite,Inc. IYN Class II 2005-08-11
K052001 MODEL SR-115 PORTABLE X-RAY SYSTEM Source-Ray, Inc. IZL Class II 2005-08-11
K052039 GE OEC ALTITUDE Ge Oec Medical Systems IZI Class II 2005-08-11
K051902 NIO 2MP-21 Barcoview LLZ Class II 2005-08-11
K051967 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS GE Healthcare KPR Class II 2005-08-09
K052042 SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS Sonoscape Company Limited IYN Class II 2005-08-09
K052113 DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2005-08-09
K051941 CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM Accuray, Inc. MUJ Class II 2005-08-09
K052029 SYNGO CIRCULATION Siemens AG Medical Solutions JAK Class II 2005-08-09
K051754 ORTHOSCAN, ORTHOSCAN HD Orthoscan, Inc. OXO Class II 2005-08-09
K051586 VIEWSEND MEDICAL SYSTEM Kenei Co., Ltd. LLZ Class II 2005-08-04
K051851 AVISO OPHTHALMIC ULTRASOUND SYSTEM Quantel Medical IYO Class II 2005-08-03
K051855 VENTRI Ge Medical Systems F.I. Haifa KPS Class II 2005-08-02
K051618 SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 Midwest Rf, LLC MOS Class II 2005-08-02
K052013 ACHIEVA 1.5T & INERA 1.5T FAMILY Philips Medical Systems Nederland B.V. LNH Class II 2005-08-02
K051649 VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 Camtronics Medical Systems LLZ Class II 2005-08-02
K051715 STARPACS DENTAL Infinitt Co., Ltd. LLZ Class II 2005-08-02
K051639 AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM As Software, Inc. LLZ Class II 2005-08-02
K051739 POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. Multigon Industries, Inc. IYN Class II 2005-07-28
K051921 THE EDGE DETECTOR, MODEL 1118 Sun Nuclear Corp. IYE Class II 2005-07-27
K051743 R2 BREAST IMAGING WORKSTATION R2 Technology, Inc. LLZ Class II 2005-07-25
K050862 3TP WORKSPACE 3tp, LLC LLZ Class II 2005-07-25
K051837 MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 Esaote, S.p.A. IYN Class II 2005-07-20
K051528 MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE Mevis Technology GmbH & Co. KG LLZ Class II 2005-07-20
K051523 REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION Konica Minolta Medical & Graphic, Inc. LLZ Class II 2005-07-20
K051497 VITESSE 2.0 Varian Medical Systems, Inc. MUJ Class II 2005-07-18
K051673 XELERIS 2 PROCESSING AND REVIEW WORKSTATION GE Medical Systems LLZ Class II 2005-07-18
K051833 TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER Toshiba America Medical Systems, In.C JAK Class II 2005-07-15
K051763 QD KNEE/FOOT COIL, MODEL MJQJ-147A Toshiba America Medical Systems, In.C MOS Class II 2005-07-14
K051765 CERETOM, MODEL NL3000 Neurologica Corporation JAK Class II 2005-07-14
K051403 19-INCH (48CM) COLOR LCD MONITOR CDL1904A Totoku Electric Co., Ltd. LLZ Class II 2005-07-14
K051745 ECHOSYSTEM Medstrat, Inc. LLZ Class II 2005-07-14
K051549 CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM Digirad Corp. KPS Class II 2005-07-13
K051553 FUJI SYNAPSE WORKSTATION SOFTWARE Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2005-07-07
K051490 GE OEC EVERVIEW 7500 Ge Oec Medical Systems, Inc. OXO Class II 2005-07-07
K051602 AXIOM SIRESKOP SD Siemens Medical Systems, Inc. JAA Class II 2005-07-07
K051418 DIRECT DIGITIZER REGIUS MODEL 370 Konica Minolta Medical & Graphic, Inc. MQB Class II 2005-07-01
K051136 SMITH & NEPHEW CDS SYSTEM Smith & Nephew, Inc. JAA Class II 2005-07-01
K042791 INSTANT-X, MODELS 1713 & 128 Ann Arbor Digital Devices MQB Class II 2005-07-01
K051423 MICK HDR INTERSTITIAL IMPLANT ACCESSORIES Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2005-07-01
K042875 NAVIGATOR Nomos Corp. IYE Class II 2005-07-01
K051392 BTI-SCAN, VERSION 4.0 B.T.I. Biotechnology Institute, Sl. LLZ Class II 2005-06-29
K051037 IMAGEQUBE PACS Intuitive Imaging Informatics, LLC LLZ Class II 2005-06-28
K051512 CAC-127-8 CARDOAC ARRAY COIL Invivo Corp. MOS Class II 2005-06-28
K051521 REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION Konica Minolta Medical & Graphic, Inc. LLZ Class II 2005-06-28
K050728 OPEN BREAST COIL (OBC) WITH BIOPSY PLATES Usa Instruments, Inc. MOS Class II 2005-06-28
K051331 19-INCH (48 CM) COLOR LCD MONITOR CDL1902A Totoku Electric Co., Ltd. LLZ Class II 2005-06-27
K051349 3.0T PROSTATE IMAGING SYSTEM Medrad, Inc. MOS Class II 2005-06-23
K051483 KODAK DIRECTVIEW DR SYSTEM DETECTOR Eastman Kodak Company MQB Class II 2005-06-21
K051500 FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A Toshiba America Medical Systems, In.C IYO Class II 2005-06-17
K051449 GE VIVID 7 WITH OR WITHOUT SUFFIX GE Medical Systems IYN Class II 2005-06-16
K051460 C.CAM-AC Danish Diagnostic Development A/S KPS Class II 2005-06-15
K051325 WEBPAX, MODEL 200 Heart Imaging Technologies, LLC LLZ Class II 2005-06-15
K051315 MODIFICATION TO: SECTRA IDS5 WORKSTATION Sectra Imtec AB LLZ Class II 2005-06-15
K051402 ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM Gvi Technology Partners IYX Class I 2005-06-13
K051351 PRECEDENCE SPECT/CT IMAGING SYSTEM Adac Laboratories KPS Class II 2005-06-08
K051304 ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM Science Surgical Corporation IYO Class II 2005-06-03
K051334 TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER Teratech Corp. IYN Class II 2005-06-03
K051127 KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 Kika Medical, Inc. LLZ Class II 2005-06-03
K050925 DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE Shimadzu Corp. MQB Class II 2005-06-01
K051022 GAMMAPLAN Elekta Instrument AB IWB Class II 2005-06-01
K051133 ARCADIS AVANTIC Siemens Medical Solutions USA, Inc. OXO Class II 2005-06-01
K051308 MYLAB 70 ULTRASOUND IMAGING SYSTEM Esaote, S.p.A. IYN Class II 2005-06-01
K051258 KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 Eastman Kodak Company KPR Class II 2005-06-01
K051201 E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY Barcoview LLZ Class II 2005-05-26
K050718 DDRCOMBI TRAUMA Swissray International, Inc. MQB Class II 2005-05-26
K050980 ULTRASONIC BIO-MICROSCOPE, MODEL P60 Paradigm Medical Industries, Inc. IYO Class II 2005-05-26
K050846 B-CAD SYSTEM, VERSION 1.0 The Medipattern Corporation LLZ Class II 2005-05-26
K050993 MMS VIDEO OPTION Medical Measurement Systems B.V. LLZ Class II 2005-05-26
K051064 ZIEHM QUANTUM Ziehm Imaging, Inc. OWB Class II 2005-05-26
K050888 INTEGRA IMMOBILIZATION SYSTEM Diacor, Inc. IYE Class II 2005-05-23
K051170 GEMINI GXL Philips Medical Systems (Cleveland), Inc. KPS Class II 2005-05-23
K050943 GE VIEWPOINT General Electric Co. LLZ Class II 2005-05-23
K051055 INTRABEAM SYSTEM Carl Zeiss Surgical GmbH JAD Class II 2005-05-23
K041971 WIMRT MODULE FOR ARTP PLANNING SYSTEM Prodigm Group, Inc. MUJ Class II 2005-05-20
K051139 ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2005-05-13
K051025 FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM Hologic, Inc. JAA Class II 2005-05-13
K051081 ESSENPACS Cymed Engineering, Inc. LLZ Class II 2005-05-12
K050996 O-ARM IMAGING SYSTEM Breakaway Imaging, LLC OXO Class II 2005-05-05
K050736 IMORGON ULTRASOUND PACS SOLUTIONS Sea Ridge Software, Inc. LLZ Class II 2005-05-05
K051085 DOPPLER-BOX Compumedics Germany Gmgh IYN Class II 2005-05-05
K043409 ACCUCHANGER Direx Systems Corp. IYE Class II 2005-05-05
K050866 CENTRION 500 C-ARM SYSTEM Osteosys Co.,Ltd JAA Class II 2005-04-27
K050987 DIGITAL RADIOGRAPHY MODEL CXDI-40EG Canon, Inc. MQB Class II 2005-04-27
K050815 XACT.CARDIAC & XPRESS.CARDIAC Ultraspect , Ltd. KPS Class II 2005-04-26
K050619 20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB Totoku Electric Co., Ltd. LLZ Class II 2005-04-26
K050617 21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB Totoku Electric Co., Ltd. LLZ Class II 2005-04-22
K050616 21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB Totoku Electric Co., Ltd. LLZ Class II 2005-04-21
K050703 QBRAIN Medis Medical Imaging Systems BV LLZ Class II 2005-04-21
K050744 KAVO ERGOCOM/ERGOCAM Kavo America Corporation LLZ Class II 2005-04-21
K050810 AGFA CR50.0 Agfa Corp. MQB Class II 2005-04-21
K050751 IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X Agfa Corp. LLZ Class II 2005-04-21

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