meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
28
Latest Decision
2011-10-27

Clearances · page 61 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K112604 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) Totoku Electric Co., Ltd. LLZ Class II 2011-10-27
K103348 DIGIVIEW 250 Kub Technologies, Inc. MQB Class II 2011-10-20
K110919 CARESTREAM PACS Carestream Health, Inc. LLZ Class II 2011-10-20
K112661 VIZION DR Viztek, LLC MQB Class II 2011-10-20
K112974 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Curve Dental, Inc. LLZ Class II 2011-10-20
K111979 RADIOACTIVE SEED LOCALIZATION NEEDLE Biocompatibles, Inc. KXK Class II 2011-10-18
K111311 SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING Omisa Inc. (Segasist Technologies) MUJ Class II 2011-10-17
K111990 CORONIS 5MP Barco N.V. LLZ Class II 2011-10-17
K112439 SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 Fujifilm Medical System U.S.A., Inc. LLZ Class II 2011-10-17
K110646 BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER Beam-Med, Ltd. MUA Class II 2011-10-12
K112051 LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE Broncus Technologies, Inc. LLZ Class II 2011-10-12
K112646 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2011-10-12
K112446 TOMOTHERAPY TREATMENT SYSTEM Tomotherapy Incorporated MUJ Class II 2011-10-07
K112460 MULTIPLE Larson Medical Products, Inc. IYE Class II 2011-10-07
K111566 DRYVIEW CHROMA IMAGING SYSTEM Carestream Health, Inc. LMC Class II 2011-10-06
K103485 SENOGRAPH DS, SENOGRAPH ESSENSTIAL General Electric Company MUE Class II 2011-10-06
K111583 FLAATZ 560 Drtech Corp. MQB Class II 2011-10-04
K110870 APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C IYN Class II 2011-10-04
K111551 OEC(R) 9800, OEC(R) 9800 PLUS Ge Oec Medical Systems, Inc. OWB Class II 2011-10-04
K112530 3DI INCLUDING CSCORE Shina Systems , Ltd. LLZ Class II 2011-09-30
K111865 WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE Fujifilm Medical System U.S.A., Inc. MQB Class II 2011-09-30
K103327 DISCOVERY MR750W 3.0T Ge Healthcare Japan Corporation LNH Class II 2011-09-30
K112096 IMAGELINK Computer Programs and Systems, Inc. LLZ Class II 2011-09-30
K111676 APEX Elekta Limited IXI Class II 2011-09-30
K111019 SURGIMAP (TM) SPINE Nemaris, Inc. LLZ Class II 2011-09-30
K112293 HTS EXTREMITY COIL, HTS SURFACE COIL Time Medical Systems, Inc. MOS Class II 2011-09-30
K112726 SONIX ULTRASOUND SCANNER Ultrasonix Medical Corporation IYN Class II 2011-09-27
K110673 HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. IYN Class II 2011-09-27
K112371 LOGIQ P3 GE Healthcare IYN Class II 2011-09-27
K111641 SURGICASE ORTHOGNATHIC SOFTWARE WIZARD Materialise NV LLZ Class II 2011-09-26
K111496 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR Totoku Electric Co., Ltd. LLZ Class II 2011-09-26
K111361 PLANMED NUANCE EXCEL Planmeca USA, Inc. MUE Class II 2011-09-23
K112122 VENUE 40 GE Healthcare IYN Class II 2011-09-23
K111791 LUMAGEM MOLECULAR BREAST IMAGING SYSTEM Gamma Medica-Ideas Incorporated IYX Class I 2011-09-23
K112474 CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE Cedars-Sinai Medical Center KPS Class II 2011-09-23
K110572 MAMMODIAGNOST DR Philips Medical Systems MUE Class II 2011-09-23
K111989 CORONIS FUSION 4MP DL Barco N.V. LLZ Class II 2011-09-22
K112022 DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Advanced Instrumentations, Inc. IYO Class II 2011-09-22
K111973 VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET Nucletron JAQ Class II 2011-09-21
K111833 VIRTUE Diagnosoft, Inc. LLZ Class II 2011-09-21
K111912 MOBILETT MIRA Siemens Medical Solutions USA, Inc. IZL Class II 2011-09-19
K112596 ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI IYN Class II 2011-09-16
K112451 S8 DIAGNOSTIC ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2011-09-16
K111731 MOLECULAR BREAST IMAGING SOFTWARE Gamma Medica-Ideas Incorporated LLZ Class II 2011-09-15
K101898 R4 ACERT ULTRASOUND REPORTING SYSTEM R4, LLC LLZ Class II 2011-09-15
K111694 ASTRA Candelis, Inc. LLZ Class II 2011-09-15
K103515 EQUAL DOSE Nucletron Corporation MUJ Class II 2011-09-15
K110033 FEEL-DRCS Imfou Co., Ltd. LLZ Class II 2011-09-15
K112366 4CH FLEX SPEEDER Toshiba Medical Systems Coporation, Japan MOS Class II 2011-09-15
K111660 XELIS CARDIAC Infinitt Co., Ltd. LLZ Class II 2011-09-13
K111759 .DECIMAL ELECTRON APERTURE .Decimal, Inc. IXI Class II 2011-09-09
K111060 MRGFUS PELVIC PA COIL MODEL 1.0 Insightech, Ltd. MOS Class II 2011-09-09
K103489 GE VEO RECONSTRUCTION OPTION General Electric Co. JAK Class II 2011-09-09
K112313 TOSHIBA 3T EXTRA LARGE KNEE COIL Quality Electrodynamics MOS Class II 2011-09-09
K111346 RESOLUTIONMD MOBILE MODEL RMB-MOB-2X Calgary Scientific, Inc. LLZ Class II 2011-09-09
K111802 SV BRAIN ARRAY, SIEMENS 3T Mri Interventions, Inc. MOS Class II 2011-09-08
K111613 XELIS FUSION Infinitt Co., Ltd. LLZ Class II 2011-09-08
K112309 DIGITAL RADIOGRAPHY Canon Inc. -Medical Equipment Group MQB Class II 2011-09-02
K111682 DIGITAL RADIOGRAPHY Canon Inc. -Medical Equipment Group MQB Class II 2011-09-02
K112213 VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM GE Healthcare IYN Class II 2011-09-01
K110729 ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM Fujifilm Medical Systems U.S.A, Inc. MUE Class II 2011-09-01
K111548 WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE Fujifilm Medical System U.S.A., Inc. MQB Class II 2011-08-30
K112339 ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2011-08-29
K103308 AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE KARL STORZ Endoscopy-America, Inc. LLZ Class II 2011-08-29
K103181 ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Genoray Co., Ltd. LLZ Class II 2011-08-26
K111633 AQUILION LB MOVEMENT BASE KIT Toshiba America Medical Systems, In.C JAK Class II 2011-08-25
K112112 SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS Sentinel Medical, Inc. MOS Class II 2011-08-25
K111373 CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE Circle Cardiovascular Imaging, Inc. LLZ Class II 2011-08-23
K110828 DDRELEMENT Swissray Medical AG KPR Class II 2011-08-23
K111508 TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 Hologic, Inc. MWP Class II 2011-08-19
K112020 SYNGO.CT VASCULAR ANALYSIS Siemens Medi Cal Solutions, Inc. JAK Class II 2011-08-18
K103659 CS 9300, CS 9300C Trophy OAS Class II 2011-08-18
K103274 SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING Sentinelle Medical, Inc. MOS Class II 2011-08-18
K111167 XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT Velopex International, Inc. IXW Class II 2011-08-18
K111106 TRUEBEAM Varian Medical Systems, Inc. IYE Class II 2011-08-18
K103448 BRIVO XR385 Ge Medical Systems, LLC KPR Class II 2011-08-12
K111347 ISROBOT MONA LISA Biobot Surgical Pte., Ltd. IYO Class II 2011-08-12
K111991 NIO COLOR 2MP Barco N.V. LLZ Class II 2011-08-11
K102078 RADIOLOGICAL IMAGE PROCESSING SYSTEM VATECH Co., Ltd. LLZ Class II 2011-08-10
K111201 C7 XR IMAGING SYSTEM Lightlab Imaging, Inc. NQQ Class II 2011-08-10
K112180 I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) Infimed, Inc. OWB Class II 2011-08-10
K110856 RALCO Ralco S.R.L. IZX Class II 2011-08-10
K101517 SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY Sedecal., Sa. IZL Class II 2011-08-05
K112054 INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V Toshiba Medical Systems Corporation, Japan JAA Class II 2011-08-05
K111931 GLIASITE RTS Isoray Medical, Inc. KXK Class II 2011-08-05
K111319 IBIS EXPLORER AND MARKUP SOFTWARE Medqia LLZ Class II 2011-08-05
K111945 IMPAX NEXT GENERATION Agfa Healthcare N.V. LLZ Class II 2011-08-05
K110801 WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM Direct Digital Imaging Technology (Beijing), Inc. MQB Class II 2011-08-02
K102489 VANTAGE TITAN 3T Toshiba Medical Systems Corporation, Japan LNH Class II 2011-08-02
K111245 HEARTNAVIGATOR RELEASE 1 Philips Medical Systems Nederland B.V. LLZ Class II 2011-07-29
K103130 XELIS 3D Infinitt Co., Ltd. LLZ Class II 2011-07-28
K111804 INTELLISPACE PACS 4.X Philips Healthcare Informatics, Inc. LLZ Class II 2011-07-28
K111892 VITREAVIEW SOFTWARE 6.1 Vital Images, Inc. LLZ Class II 2011-07-28
K111222 MRI-Q SYSTEM Resonance Health Analysis Services Pty, Ltd. LLZ Class II 2011-07-28
K111582 LOGIQ S8 GE Healthcare IYN Class II 2011-07-26
K111209 INTEGRATED INNOVA - S5I SYSTEM OPTION GE Healthcare IZI Class II 2011-07-26
K110942 PICA WHOLE-BODY MRI SYSTEM Time Medical Limited LNH Class II 2011-07-26
K111302 MYLABSEVEN, MYLABALPHA Esaote, S.p.A. IYN Class II 2011-07-22
K110943 LOGIQ E9 GE Healthcare IYN Class II 2011-07-22
K111299 AXXENT RADIATION SHIELD - RIGID Xoft, an Icad Company JAD Class II 2011-07-20

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