meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
26
Latest Decision
2012-08-28

Clearances · page 58 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112255 AIXPLORER Supersonic Imagine IYN Class II 2012-08-28
K121329 AIXPLORER Supersonic Imagine IYN Class II 2012-08-24
K121854 SYSTEM, X-RAY, STATIONARY Beijing Sinopharm Hundric Mediline Info. Tech. Co. KPR Class II 2012-08-22
K121063 VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM Ge Medical System Israel , Ltd. IYN Class II 2012-08-21
K121910 OCTAVE SPEEDER HEAD Toshiba Medical Systems Corporation, Japan MOS Class II 2012-08-17
K121062 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM Ge Medical System Israel , Ltd. ITX Class II 2012-08-17
K121911 OCTAVE SPEEDER SPINE Toshiba Medical Systems Corporation, Japan MOS Class II 2012-08-17
K113715 LUNG VOLUME ANALYSIS Toshibamedical Systems Corporation JAK Class II 2012-08-17
K122234 OEC 9900 ELITE Ge Healthcare Surgery GE Oec Medical Systems, Inc. OWB Class II 2012-08-16
K122182 DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC Rayence Co., Ltd. MQB Class II 2012-08-16
K121095 DX-D IMAGING PACKAGE Agfa Healthcare N.V. MQB Class II 2012-08-16
K121422 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM Toshiba Medical Systems Coporation, Japan IYO Class II 2012-08-16
K122329 BIOJET Jet Soft Srl LLZ Class II 2012-08-16
K122205 EXINI Exini Diagnostics AB LLZ Class II 2012-08-15
K120789 EXACTRAC X-RAY X-RAY Brainlab AG IYE Class II 2012-08-14
K121997 IMRIS ONCOLOGY PACKAGE Imris, Inc. LNH Class II 2012-08-10
K113607 BIOPSY DIGIT S BIOPSY SL Giotto USA, LLC IZH Class II 2012-08-10
K113210 ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT Isoaid, LLC KXK Class II 2012-08-10
K121513 MULTIX FUSION Siemens Medical Solution KPR Class II 2012-08-10
K122006 G-SCAN BRIO Esaote, S.p.A. LNH Class II 2012-08-06
K120451 8MP COLOR LCD MONITOR, REDIFORCE RX840 Eizo Nanao Corporation LLZ Class II 2012-08-03
K112692 IDENTIFY Humediq GmbH IYE Class II 2012-08-03
K121410 DRAGON LW Sedecal., Sa. IZL Class II 2012-08-02
K121867 SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS Chison Medical Imaging Co., Ltd. IYN Class II 2012-08-02
K120734 MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE Microsoft Corp. LLZ Class II 2012-08-02
K120668 SENTINEL C-Rad Positioning AB IYE Class II 2012-07-30
K121292 DYNAPBV BODY SOFTWARE Siemens Medical Solutions USA, Inc. LLZ Class II 2012-07-30
K121075 NERVEVISION SOFTWARE SYSTEMS 3D Imaging Partners, Inc. LLZ Class II 2012-07-26
K121553 AQUILION RXL Toshibamedical Systems Corporation JAK Class II 2012-07-26
K120993 GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER Varian Medical Systems, Inc. JAQ Class II 2012-07-26
K121888 E-CUBE 15 Alpinion Medical Systems Co., Ltd. IYO Class II 2012-07-26
K121937 E-CUBE INNO Alpinion Medical Systems Co., Ltd. IYN Class II 2012-07-26
K121293 CS-SERIES-FP WITH 3030+OPTION Omega Medical Imaging, LLC JAA Class II 2012-07-26
K121303 MOBILE C-ARM Canon Inc. -Medical Equipment Group OXO Class II 2012-07-26
K120753 CLARISCT Icrco, Inc. OAS Class II 2012-07-26
K121195 NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER Ninepoint Medical, Inc. NQQ Class II 2012-07-25
K121788 NIO 5MP Barco N.V. LLZ Class II 2012-07-23
K122010 Z6 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2012-07-20
K121517 VERSAVUE ENTERPRISE SUITE Icad, Inc. LLZ Class II 2012-07-20
K121948 CR 10-X DIGITIZER Agfa Healthcare N.V. MQB Class II 2012-07-20
K113754 CFR QUANT University of Texas Medical School AT Houston KPS Class II 2012-07-19
K121160 MAGNETOM SPECTRA Siemens Medical Solutions USA, Inc. LNH Class II 2012-07-16
K113562 3MP COLOR LCD MONITOR, RADIFORCE RX340 Eizo Nanao Corporation LLZ Class II 2012-07-16
K113620 MYRIAN 1.11 Intrasense LLZ Class II 2012-07-12
K113421 MINICAT Xoran Technologies, Inc. JAK Class II 2012-07-11
K121838 LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM Liebel-Flarsheim MQB Class II 2012-07-11
K121449 DIRECTPATH Cybernet Systems Co., Ltd. LLZ Class II 2012-07-10
K121807 V5MS TRANSDUCER Siemens Medical Solutions USA, Inc. ITX Class II 2012-07-10
K121650 S-SCAN Esaote, S.p.A. LNH Class II 2012-07-09
K120305 THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV Thinking Systems Corp. LLZ Class II 2012-07-09
K120514 CARDIOPACS Lumedx LLZ Class II 2012-07-05
K120636 SYNAPSE 3D CARDIAC TOOLS Fujifilm Medical System U.S.A., Inc. LLZ Class II 2012-07-05
K120733 SIMPLANT GO Materialise Dental NV LLZ Class II 2012-07-05
K121448 ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY Elekta Inc. D/B/A Nucletron Corporation MUJ Class II 2012-07-02
K120520 EXACTRAC ROBOTICS NOVALIS ROBOTICS Brainlab AG JAI Class II 2012-06-29
K121295 ARTISTETM SOLUTION WITH SYS VCIO Siemens Medical Solutions USA, Inc. IYE Class II 2012-06-27
K121699 ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2012-06-22
K120472 QUANTRA Hologic, Inc. LLZ Class II 2012-06-22
K112827 SHEATHES ULTRASOND GEL Sheathing Technologies, Inc. MUI Class II 2012-06-22
K121646 ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. Ultrasound Gro IYN Class II 2012-06-22
K121577 APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM Toshiba Medical Systems Corporation, Japan IYN Class II 2012-06-22
K121459 SYNGO.MR NEUROLOGY Siemens Medical Solutions USA, Inc. LLZ Class II 2012-06-22
K120916 QFIX RADIOTHERAPY CHAIR Wfr/Aquaplast Corp. JAI Class II 2012-06-20
K121530 BODYFIX SYSTEM Medical Intelligence Medizintechnik GmbH IYE Class II 2012-06-20
K120910 CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL GE Medical Systems SCS JAK Class II 2012-06-18
K113456 READY VIEW Ge Healthcare (Ge Medical Systems Scs) LLZ Class II 2012-06-15
K113613 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM Shantou Institute of Ultrasonic Instuments IYN Class II 2012-06-15
K121362 1.5T 16CH FLEX SPEEDER LARGE Neocoil, LLC MOS Class II 2012-06-15
K120648 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS Fujifilm Medical System U.S.A., Inc. LLZ Class II 2012-06-14
K120801 CHISON DIAGNOSTIC ULTRASOUND SYSTEM Chison Medical Imaging Co., Ltd. IYN Class II 2012-06-14
K113449 FUSION FLAT PANEL Icrco, Inc. MQB Class II 2012-06-14
K111818 SONIXGPS NEEDLE SENSOR Ultrasonix Medical Corporation IYO Class II 2012-06-13
K120546 AQUILION PREMIUM Toshiba Medical Systems Corporation, Japan JAK Class II 2012-06-13
K121249 MULTIARRAY KIT Paramed S.R.L. MOS Class II 2012-06-12
K120833 DISCOVERY CT750 HD Ge Medical Systems, LLC JAK Class II 2012-06-12
K121328 AGILITY Elekta , Ltd. IYE Class II 2012-06-12
K121074 SCENIUM 2.0 Siemens Medical Solutions USA, Inc. LLZ Class II 2012-06-08
K121412 PAX-FLEX3D, PHT-7000 VATECH Co., Ltd. OAS Class II 2012-06-08
K120752 AERODR STITCHING SYSTEM Konica Minolta Medical & Graphic, Inc. KPR Class II 2012-06-08
K121545 BELLYBOARD, SBRT ACCESSORIES Medtec Inc. Dba Civco Medical Solutions LNH Class II 2012-06-08
K120551 SIMUPLAN TREATMENT PLANNING SYSTEM Simuplan S.L. MUJ Class II 2012-06-08
K121381 VIEWFLEX XTRA ICE CATHETER St Jude Medical IYO Class II 2012-06-07
K121444 FLAT PANEL DETECTOR Canon, Inc. - Medical Equpment Group OWB Class II 2012-06-07
K120731 TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY Varian Medical Systems, Inc. JAQ Class II 2012-06-06
K121387 CENTRICITY PACS-IW Ge Healthcare Integrated IT Solutions LLZ Class II 2012-06-05
K120676 S-250 PROTON BEAM RADIATION THERAPY SYSTEM Mevion Medical Systems LHN Class II 2012-06-04
K120638 VANTAGE TITAN Toshibamedical Systems Corporation LNH Class II 2012-06-01
K121345 SR SUITE 1.0 Halifax Biomedical, Inc. KPR Class II 2012-06-01
K120679 SYNAPSE 3D NODULE ANALYSIS Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2012-06-01
K121466 GUIDEMIA Guidemia Technologies, LLC LLZ Class II 2012-05-31
K121023 SPECTRUM V.0 Intrinsic Medical Imaging LLZ Class II 2012-05-31
K113739 SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM Materialise Dental NV LLZ Class II 2012-05-30
K120882 SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE Bard Access Systems, Inc. IYO Class II 2012-05-30
K113696 OPTOS ADVANCE Optos Plc. NFJ Class II 2012-05-25
K121236 PAX-DUO3D PLUS, PCT-5000 VATECH Co., Ltd. OAS Class II 2012-05-24
K120811 LEKSELL GAMMA KNIFE PERFEXION Elekta Instrument AB IWB Class II 2012-05-24
K121239 MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE Optoacoustics, Ltd. LNH Class II 2012-05-24
K121109 AERODR X70 Konica Minolta Medical & Graphic, Inc. KPR Class II 2012-05-23
K113287 SOMATOM PERSPECTIVE Siemens Medical Solutions USA, Inc. JAK Class II 2012-05-23
K120579 SOMATOM DEFINITION EDGE Siemens Medical Systems, Inc. JAK Class II 2012-05-23

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