meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
29
Latest Decision
2011-07-20

Clearances · page 62 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K110797 COMMUNIFY PACS VIEWER Flying Squirrel Storage, LLC LLZ Class II 2011-07-20
K110227 OPTIMA CT660 Ge Medical Systems, LLC JAK Class II 2011-07-20
K101181 BEL-CAT Takara Belmont Corp. OAS Class II 2011-07-19
K111725 MOBILEDIAGNOST WDR Sedecal., Sa. IZL Class II 2011-07-19
K111304 OPTIMA XR120 Ge Medical Systems, LLC IXL Class II 2011-07-19
K111864 E-CUBE 9 Alpinion Medical Systems Co., Ltd. IYN Class II 2011-07-15
K111706 VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM Volcano Corporation IYO Class II 2011-07-15
K111803 G-SCAN Esaote, S.p.A. LNH Class II 2011-07-15
K110869 CARA Diagnos, Inc. NFJ Class II 2011-07-14
K111312 SANTEVIEW Sehyun Co., Ltd. MQB Class II 2011-07-13
K110507 CARDIAC SCANNER AND PROCESSING SYSTEM Spectrum Dynamics (Israel) , Ltd. KPS Class II 2011-07-13
K111435 DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2011-07-08
K111259 SV DBS VRAIN ARRAY Midwest Rf, LLC MOS Class II 2011-07-05
K110300 SIMPLANT 2011 Materialise Dental NV LLZ Class II 2011-07-01
K111226 ENDOSCOUT TRACKING SYSTEM Robin Medical, Inc. LNH Class II 2011-07-01
K110839 SCANORA 3D Soredex Palodex Group OY OAS Class II 2011-06-30
K111674 ACUSON Siemens Medical Solutions USA, Inc. IYN Class II 2011-06-30
K110886 CLIO/CLIOSOFT Sota Precision Optics, Inc. LLZ Class II 2011-06-30
K102813 EZONO 3000 Life-Tech, Inc. IYN Class II 2011-06-30
K111340 HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM Medtec, Inc. LNH Class II 2011-06-28
K110752 HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER Highland Instruments ITX Class II 2011-06-28
K110900 DISPOSABLE THYROID COLLAR Bloxr Corporation KPY Class I 2011-06-24
K111513 CX50 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2011-06-24
K110730 MONACO RTP SYSTEM Computerized Medical Systems, Inc. MUJ Class II 2011-06-24
K111638 IMPAX VOLUME VIEWING Agfa Healthcare N.V. LLZ Class II 2011-06-24
K110812 CT-GUIDE NEEDLE GUIDANCE SYSTEM Activiews, Ltd. JAK Class II 2011-06-21
K110414 QLAB 8.1 QUANTIFICATION SOFTWARE Philips Ultrasound, Inc. LLZ Class II 2011-06-21
K103476 BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX Ge Medical Systems, LLC IZL Class II 2011-06-16
K111237 MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY Nec Display Solutions , Ltd. LLZ Class II 2011-06-15
K111344 I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560) Infimed, Inc. OWB Class II 2011-06-10
K103429 BIOGRAPH MMR Siemens Medical Solutions USA, Inc. OUO Class II 2011-06-08
K103724 10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030) Eizo GmbH LLZ Class II 2011-06-08
K111445 DISCOVERY NM 630 GE Healthcare KPS Class II 2011-06-03
K111292 LUMINOS AGILE Siemens Medical Solutions USA, Inc. JAA Class II 2011-06-03
K103703 REGUIS SIGMA Konica Minolta Medical & Graphic, Inc. MQB Class II 2011-06-02
K110688 MYLABGOLD Esaote IYO Class II 2011-06-02
K102811 AOS ORION IR-192 SOURCE CABLE Alpha-Omega Services, Inc. KXK Class II 2011-06-02
K102479 ALARA T210 COMPUTED RADIOGRAPHY SYSTEM Alara, Inc. MQB Class II 2011-06-02
K101952 KONIX ULTRASOUND GEL Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa ITX Class II 2011-05-27
K110785 KALARE DIAGNOSTIC X-RAY TABLE SYSTEM Toshiba Medical Systems Coporation, Japan JAA Class II 2011-05-27
K111251 4CH FLEX SPEEDER Toshiba Medical Systems Coporation, Japan MOS Class II 2011-05-27
K111098 INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN Imaging Dynamics Company , Ltd. MQB Class II 2011-05-27
K110256 THE IC-PRO SYSTEM Paieon, Inc. IZI Class II 2011-05-27
K110447 ECHOINSIGHT Ultrasound Medical Devices, Inc. LLZ Class II 2011-05-27
K111336 EBW NM 2.0 Philips Medical Systems (Cleveland), Inc. LLZ Class II 2011-05-24
K102534 AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE Aze, Ltd. LLZ Class II 2011-05-24
K103723 SICAT IMPLANT V1.2 Sicat GmbH & Co. KG LLZ Class II 2011-05-20
K111052 SYNGO NEURO PBV-IR Siemens Medical Solutions USA, Inc. LLZ Class II 2011-05-20
K110006 OIS SYMPHONY IMAGE MANAGMENT SYSTEM Ophthalmic Imaging Systems NFJ Class II 2011-05-18
K083423 COLONCAD API 3.1 Medicsight Plc NWE Class II 2011-05-17
K101779 CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM Jpi Healthcare Co, Ltd. KPR Class II 2011-05-16
K110510 S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2011-05-16
K111227 ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2011-05-13
K102619 COMPUTED RADDIOGRAPHY SCANNER 3Disc Americas MQB Class II 2011-05-13
K102748 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T Rapid Biomedical GmbH MOS Class II 2011-05-13
K111079 SYNGO.VIA WEB VIEWER Siemens AG Medical Solutions LLZ Class II 2011-05-13
K110628 SIMPLEABI Newman Medical JAF Class II 2011-05-12
K110430 DOLPHIN IMAGING Patterson Dental Supply, Inc. LLZ Class II 2011-05-11
K103633 ACHILLES Ge Medical Systems China Co., Ltd. MUA Class II 2011-05-11
K103730 GE LUNAR VISCERAL FAT SOFTWARE Ge Medical Systems Ultrasound and Primary Care Dia KGI Class II 2011-05-06
K111164 EUNITY Client Outlook, Inc. LLZ Class II 2011-05-06
K110875 CENTRICITY PACS GE Healthcare LLZ Class II 2011-05-05
K111102 RADIOVISION Haas Software LLZ Class II 2011-05-05
K110384 DILON 6800 ACELLA (ACELLA) Dilon Technologies, Inc. IYX Class I 2011-05-03
K110573 READY VIEW Ge Healthcare (Ge Medical Systems Scs) LLZ Class II 2011-05-03
K093640 DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA Electron Jsco. IXK Class II 2011-04-29
K110772 BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. IYE Class II 2011-04-28
K110025 SECTRA MICRODOSE MAMMOGRAPHY Sectra Imtec AB MUE Class II 2011-04-28
K103599 UNIVERSAL DIGITAL INTERFACE (UDI) 1717 Meridian Medical Systems, LLC MQB Class II 2011-04-27
K111021 CUBESCAN / BIOCON-700 Mcube Technology Co., Ltd. ITX Class II 2011-04-27
K110849 PRESTODR 4143 Cmt Medical Technologies, Ltd. KPR Class II 2011-04-26
K110834 AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION GE Healthcare LLZ Class II 2011-04-26
K110999 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Edan Instruments, Inc. ITX Class II 2011-04-26
K110139 CURVE IMAGE Curve Dental, Inc. LLZ Class II 2011-04-21
K111024 JETPACK 2.0 Philips Medical Systems (Cleveland), Inc. LLZ Class II 2011-04-21
K110210 SATURN 8000-GS New Medical Co., Ltd. MQB Class II 2011-04-20
K110844 SYMBIA.NET Siemens Medical Solutions USA, Inc. LLZ Class II 2011-04-20
K110487 FLEXIBLE CARDIAC COIL Lbds Holding Company MOS Class II 2011-04-19
K093581 DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS Ge Medical Systems, LLC JAK Class II 2011-04-19
K103606 ARTISTE SOLUTION WITH SYS_VB50 UPDATE Siemens Medical Solutions USA, Inc. IYE Class II 2011-04-15
K110841 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER Shantou Institute of Ultrasonic Instruments (Siui IYN Class II 2011-04-15
K103565 MEDVOXEL HEARTPRO SOFTWARE APPLICATION Medvoxel Systems, Inc. LLZ Class II 2011-04-12
K110366 SYNGO.CT CARDIAC FUNCTION Siemens AG JAK Class II 2011-04-12
K101888 SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. JAK Class II 2011-04-08
K110802 A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 Esaote, S.p.A. LNH Class II 2011-04-08
K110411 ATAMA SYSTEM Monteris Medical, Inc. MOS Class II 2011-04-08
K110667 IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS Tomtec Imaging Systems GmbH LLZ Class II 2011-04-08
K110920 UF-760AG Fukuda Denshi Co., Ltd. ITX Class II 2011-04-08
K110595 4D SONO-SCAN 1.0 Tomtec Imaging Systems GmbH LLZ Class II 2011-04-07
K110186 SYNAPSE 3D LIVER ANALYSIS Fujifilm Medical System U.S.A., Inc. LLZ Class II 2011-04-07
K110373 TEMPOROMANIBULAR COIL 15 Esaote, S.p.A. MOS Class II 2011-04-06
K110494 SYNGO MBF Siemens Medical Solutions USA, Inc. LLZ Class II 2011-04-06
K110260 NEWTOM 5G / NEWTOM 5G VERSION FP Qr S.R.L. OAS Class II 2011-04-06
K110610 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL Ge Medical Systems, LLC MOS Class II 2011-04-01
K100714 CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 Cedars-Sinai Medical Center KPS Class II 2011-04-01
K103596 WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR Fujifilm Medical Systems U.S.A, Inc. MQB Class II 2011-03-29
K103425 ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM Genoray America, Inc. OWB Class II 2011-03-29
K110591 MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL Mr Instruments, Inc. MOS Class II 2011-03-29
K103591 DIGITAL RADIOGRAPHY Canon Inc. -Medical Equipment Group MQB Class II 2011-03-29
K103038 DUET DRF Cmt Medical Technologies, Ltd. JAA Class II 2011-03-29

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