meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
24
Latest Decision
2009-05-27

Clearances · page 68 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090321 RIC CONFORMAL SOURCE, MODEL 100 Ri Consultants, LLC ONL Class II 2009-05-27
K091374 GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND Ge Medical Systems China Co., Ltd. IYO Class II 2009-05-26
K090469 CARESTREAM DRYVIEW 5850 LASER IMAGER Carestream Health, Inc. LMC Class II 2009-05-22
K090461 IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 Tomtec Imaging Systems GmbH LLZ Class II 2009-05-22
K090155 CAAS MR FLOW 1.0 Pie Medical Imaging BV LLZ Class II 2009-05-22
K091373 SYNGO TRUED Siemens Medical Solutions USA, Inc. LLZ Class II 2009-05-20
K090672 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS Agfa Healthcare N.V. MQB Class II 2009-05-18
K083327 SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 Siemens Medical Solutions USA, Inc. LLZ Class II 2009-05-18
K091154 UTRECHT INTERSTITIAL FLETCHER CT/MR APPLICATOR SET, MODEL 110.270, INTERSTITIAL RING CT/MR APPLICATOR SET,MODEL 110.330, Nucletron Corporation JAQ Class II 2009-05-18
K090062 WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM Direct Digital Imaging Technology (Beijing), Inc. MQB Class II 2009-05-18
K091009 MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 Esaote, S.p.A. IYN Class II 2009-05-18
K083545 ZIEHM VISION RFD Ziehm Imaging, Inc. OWB Class II 2009-05-15
K091295 APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 Toshiba America Medical Systems, In.C ITX Class II 2009-05-15
K091286 SYNGO US WORKPLACE Siemens Medical Solutions USA, Inc. LLZ Class II 2009-05-15
K091073 WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS Ultraspect , Ltd. KPS Class II 2009-05-14
K090833 SEGMENT Medviso LLZ Class II 2009-05-12
K091269 NEUROPET Photodetection Systems, Inc. KPS Class II 2009-05-08
K090683 SYNGO RT THERAPIST CONNECT Siemens Medical Solutions USA, Inc. IYE Class II 2009-05-08
K090505 SPEQ ULTRASOUND SYSTEM Signostics Pty, Ltd. IYO Class II 2009-05-07
K090266 MATCHEDFLICKER Eyeic Corporation NFJ Class II 2009-05-06
K091172 NIO 2MP (MDNG-2121) Barco N.V. LLZ Class II 2009-05-05
K091164 GE VENUE 40, MODEL 5324338 Ge Medical Systems China Co., Ltd. IYN Class II 2009-05-05
K091160 LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM Broncus Technologies, Inc. LLZ Class II 2009-05-05
K083502 PANTHER REALART, MODEL 4.7 Prowess, Inc. MUJ Class II 2009-05-05
K090182 MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS) Nuclemed S.A. MUJ Class II 2009-05-04
K082781 OEC 9900 ELITE Ge Healthcare Surgery OWB Class II 2009-05-01
K091114 TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL Quality Electrodynamics MOS Class II 2009-05-01
K091146 MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray, Inc. MUJ Class II 2009-05-01
K090171 COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D E-Woo Technology OAS Class II 2009-04-30
K090059 IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM Saset (Chengdu), Inc. IYO Class II 2009-04-30
K090038 SYNGO BREVIS Siemens Medical Solutions USA, Inc. LNH Class II 2009-04-28
K090178 ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 Neusoft Positron Medical Systems Co., Ltd. KPS Class II 2009-04-24
K090366 SPEC MODEL M-31 Source Production & Equipment Co., Inc. KXK Class II 2009-04-22
K090607 BLUE SKY BIO PLAN, VERSION .38 Blue Sky Bio, LLC LLZ Class II 2009-04-22
K090603 BARCO 5MP MAMMO, MODEL MDMG-5221 Barco N.V. LLZ Class II 2009-04-22
K090732 NIO COLOR 3MP AND MDNC-3121 Barco N.V. LLZ Class II 2009-04-20
K090218 MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ Nec Display Solutions , Ltd. LLZ Class II 2009-04-15
K083910 VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER Vidistar, LLC LLZ Class II 2009-04-15
K090912 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ITX Class II 2009-04-15
K083058 IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A. LHN Class II 2009-04-15
K090215 MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL Nec Display Solutions , Ltd. LLZ Class II 2009-04-15
K083672 P.D SOFTWARE .Decimal, Inc. MUJ Class II 2009-04-13
K090873 I OPEN 0.5T Beijing Wandong Medical Equipment Co., Ltd. LNH Class II 2009-04-10
K090465 DIGDOP ULTRASOUND SYSTEM The Newman Group, LLC ITX Class II 2009-04-08
K090318 CARESTREAM DRX-1 SYSTEM Carestream Health, Inc. MQB Class II 2009-04-06
K090808 PINNACLE3 SMARTARC Philips Medical Systems, Inc. MUJ Class II 2009-04-03
K083539 INFANT CARDIAC ARRAY Advanced Imaging Research, Inc. MOS Class II 2009-04-03
K090743 YIELD MINI DOPPLER SYSTEM Broncus Technologies, Inc. IYN Class II 2009-04-03
K083524 SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY Siemens Medical Solutions USA, Inc. JAK Class II 2009-04-01
K083114 ACUSON P50 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2009-03-31
K090403 AUTOSPECT Philips Medical Systems (Cleveland), Inc. KPS Class II 2009-03-31
K090553 NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER Naviscan, Inc. KPS Class II 2009-03-31
K090223 ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024 Icad, Inc. LLZ Class II 2009-03-31
K083446 CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING Ziosoft, Inc. LLZ Class II 2009-03-31
K082582 SENTINEL, MODEL SP-001 C-Rad Positioning AB IYE Class II 2009-03-30
K090649 VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE Virtual Radiologic Corporation LLZ Class II 2009-03-27
K090433 I_OPEN 0.4T Beijing Wandong Medical Equipment Co., Ltd. LNH Class II 2009-03-25
K090439 FORUM Carl Zeiss Meditec, Inc. NFJ Class II 2009-03-25
K090623 DIGITAL RADIOGRAPHY CXDI-40G COMPACT Canon USA, Inc. MQB Class II 2009-03-24
K090625 WIRELESS PORTABLE DETECTOR FD-W17 Philips Medical Systems North America Co. MQB Class II 2009-03-24
K083224 CPI RAD VISION, MODEL VZW2944XX-YY Communications & Power Industries Canada, Inc. MQB Class II 2009-03-24
K081168 BRIT PACS SYSTEMS Brit Systems, Inc. LLZ Class II 2009-03-23
K090080 CIRRUS OPEN Mri-Tech Sp. Zo.O. LNH Class II 2009-03-23
K083852 BIOGRAPH 16 TRUE POINT SYSTEMS Siemens Medical Solutions USA, Inc. KPS Class II 2009-03-23
K090481 DEMASQ IMAGING SPFTWARE DEVICE Demasq Limited LLZ Class II 2009-03-19
K090322 EASY MOVING PLUS, SM-XXHF-YY Sedecal., Sa. IZL Class II 2009-03-17
K090552 UROCARE Neusoft Medical Systems Co., Ltd. LLZ Class II 2009-03-16
K090590 VERADIUS, MODEL 718-130 Philips Medical Systems North America Co. OWB Class II 2009-03-16
K090267 SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64 Midwest Rf, LLC MOS Class II 2009-03-16
K090214 VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND Verathon Incorporated IYO Class II 2009-03-13
K090229 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV Chang Gung Medical Supplies & Equipment Corp. IYN Class II 2009-03-13
K090095 LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM Broncus Technologies, Inc. LLZ Class II 2009-03-13
K090279 SEDECAL, MILLENNIUM PLUS Sedecal., Sa. KPR Class II 2009-03-11
K083649 CARDIUS 3 X-ACT Digirad Corp. KPS Class II 2009-03-09
K082964 PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5) Prism Clinical Imaging, Inc. LNH Class II 2009-03-09
K090349 CLEARVUE PRONE BREAST TREATMENT TABLE Orbital Therapy, LLC IYE Class II 2009-03-09
K090504 CSBP-001A BODY PERFUSION SYSTEM Toshibamedical Systems Corporation JAK Class II 2009-03-05
K083182 DATACOM DC PACS Datacom Technology Corp. LLZ Class II 2009-03-04
K090295 BODYVIZ, MODEL 100 Visual Medical Solutions, LLC LLZ Class II 2009-03-04
K083414 RADIONICS XKNIFE HDRT SYSTEM Integra Radionics, Inc. MUJ Class II 2009-03-02
K090238 SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS Sedecal., Sa. KPR Class II 2009-02-27
K083691 BONEVUE Micromri, Inc. LLZ Class II 2009-02-25
K082623 VISIX IMAGING Televere Systems LLZ Class II 2009-02-25
K083645 RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS 5 Star Medical, Inc. MQB Class II 2009-02-24
K083541 NEONATE HEAD AND BODY COILS Advanced Imaging Research, Inc. MOS Class II 2009-02-24
K082693 RESOLUTIONMD, RELEASE 2.1 Calgary Scientific, Inc. LLZ Class II 2009-02-23
K090334 ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medi Cal Solutions, Inc. IYN Class II 2009-02-20
K083491 NEUROSCAPE Olea Medical LLZ Class II 2009-02-19
K090296 ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 Biodex Medical Systems, Inc. KPT Class II 2009-02-19
K082775 PRESCISION OPTION Siemens Medical Solutions USA, Inc. IYE Class II 2009-02-19
K083533 ECHELON C MRI SYSTEM Hitachi Medical Systems America, Inc. LNH Class II 2009-02-17
K083745 THE IC-PRO SYSTEM, MODEL VERSION 3.2 Paieon, Inc. IZI Class II 2009-02-17
K083503 DRAD30003/RADREX-I Toshiba America Medical Systems, In.C KPR Class II 2009-02-13
K083740 MAMMODIAGNOST VU Philips Medical Systems Nederland B.V. LLZ Class II 2009-02-13
K083734 AXXENT SURFACE APPLICATOR, MODEL 710257 Xoft, Inc. JAD Class II 2009-02-11
K090220 COLON VIEW, MODEL CSCV-001A Toshibamedical Systems Corporation JAK Class II 2009-02-11
K083824 HUMANSCAN M5S-D ULTRASOUND TRANSDUCER Humanscan Company, Ltd. ITX Class II 2009-02-10
K090158 APLIO ARTIDA V2.0 SSH-880CV Toshiba America Medical Systems, In.C IYN Class II 2009-02-06
K090173 NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd. JAK Class II 2009-02-05
K090119 SICAT IMPLANT Sicat GmbH & Co. KG LLZ Class II 2009-02-05

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