meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
27
Latest Decision
2010-03-01

Clearances · page 66 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K100079 DIGITAL ULTRASOUND SCANNER Shenzhen Well.D Medical Electronics Co., Ltd. IYO Class II 2010-03-01
K100267 FLEXIMARC, MODEL CM-0.9-2-10-GG-L Cortex Manufacturing, Inc. IYE Class II 2010-02-24
K093621 SYNGO.PET&CT ONCOLOGY Siemens Medical Solutions USA, Inc. LLZ Class II 2010-02-23
K100092 CORVUS RADIATION THERAPY PLANNING SYSTEM Best Nomos MUJ Class II 2010-02-23
K100204 SONALIS Smith Associates ITX Class II 2010-02-19
K093688 CANON, MODEL URS-50RF Virtual Imaging, Inc. OWB Class II 2010-02-04
K093444 EXAPACS Medincom Technology Corp LLZ Class II 2010-02-04
K093572 R650 QDASM COLLIMATOR Omega Medical Imaging, Inc. IZW Class II 2010-02-03
K093284 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL Invivo Corporation MOS Class II 2010-02-01
K093563 IU22 ULTRASOUND SYSTEM AND TRANSDUCERS Philips Ultrasound, Inc. IYN Class II 2010-02-01
K100067 MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C ITX Class II 2010-01-28
K093667 SHOULDER SPEEDER COIL Quality Electrodynamics MOS Class II 2010-01-28
K093995 IG 4 IMAGE GUIDED SYSTEM Veran Medical Technologies, Inc. JAK Class II 2010-01-27
K092845 RESPISENS Nomics IYE Class II 2010-01-26
K093427 FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR Fujifilm Medical System U.S.A., Inc. MQB Class II 2010-01-21
K093693 NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH Noras Mri Products GmbH MOS Class II 2010-01-19
K093713 ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM Civco Medical Instruments ITX Class II 2010-01-19
K093849 ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2010-01-19
K093703 3DI Shina Systems , Ltd. LLZ Class II 2010-01-19
K093596 LUMOS, MODEL R 72B Lumos, Inc. KPW Class II 2010-01-12
K092479 SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL Dyn'R IYE Class II 2010-01-11
K093588 EXPLORER 4D TREATMENT PLANNING SYSTEM American Radiosurgery, Inc. MUJ Class II 2010-01-11
K093982 XELERIS 3 PROCESSING AND REVIEW WORKSTATION Ge Medical Systems F.I. Haifa LLZ Class II 2010-01-08
K090467 DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D VATECH Co., Ltd. OAS Class II 2010-01-08
K093355 PCR ELEVA 1.2 Philips Medical Systems, Inc. LLZ Class II 2010-01-08
K093809 VIDAR DENTAL FILM DIGITIZER Vidar Systems Corp. LMA Class II 2010-01-07
K092925 3D ASL Ge Medical Systems, LLC LNH Class II 2010-01-06
K093503 INTRAX FILM PROCESSOR Velopex International, Inc. IXW Class II 2010-01-06
K093520 VIVOSIGHT TOPICAL OCT SYSTEM Michelson Diagnostics, Ltd. NQQ Class II 2010-01-05
K093250 PROTON THERAPY MULTILEAF COLLIMATOR Varian Medical Systems LHN Class II 2009-12-24
K093393 LIFEDOP MODEL 300ABI Summit Doppler Systems, Inc. JAF Class II 2009-12-24
K093663 RADIONUCLIDE BRACHYTHERAPY SOURCE C.R. Bard, Inc. KXK Class II 2009-12-23
K093613 VASCUVIEW TAP ULTRASOUND SYSTEM Escalon Medical Corp. IYN Class II 2009-12-23
K092469 O-SCAN MR SYSTEM Esaote, S.p.A. LNH Class II 2009-12-23
K092837 OTI-SCAN 3000 Opko Instrumentation, Inc. IYO Class II 2009-12-23
K092438 ZIEHM SOLO Ziehm Imaging, Inc. OWB Class II 2009-12-23
K093391 SIMUPLAN TREATMENT PLANNING SYSTEM Simuplan S.L. MUJ Class II 2009-12-23
K092796 IBA PROTON THERAPY SYSTEM, PROTEUS 235 Ion Beam Applications S.A. LHN Class II 2009-12-22
K093090 GALILEOS IMPLANT, VERSION 1.7 Sicat GmbH & Co. KG LLZ Class II 2009-12-17
K092928 DOSE VOLUME HISTOGRAM (DVH) EVALUATOR Diversilabs, LLC MUJ Class II 2009-12-16
K093527 ARIA RADIATION ONCOLOGY WITH MIRS Varian Medical Systems, Inc. IYE Class II 2009-12-15
K092550 TIGRT IVS Linatech, LLC IYE Class II 2009-12-15
K091364 DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 Oehm Und Rehbein GmbH LLZ Class II 2009-12-11
K093117 DIGITAL LIGHTBOX Brainlab AG LLZ Class II 2009-12-11
K093672 AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION Sentinelle Medical, Inc. LLZ Class II 2009-12-11
K082588 GAMMALOC SYSTEM, MODEL 03-00001 Dilon Technologies, LLC IYX Class I 2009-12-11
K093714 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. ITX Class II 2009-12-10
K092125 PRESIDIO PACS Reaonix Security, LLC LLZ Class II 2009-12-10
K093514 DISCOVERY MODEL NM/CT 670 Ge Medical Systems F.I. Haifa KPS Class II 2009-12-10
K092534 ALATUS VAGINAL BALLOON PACKING SYSTEM Radiadyne JAQ Class II 2009-12-07
K093171 VIAMO SSA-640A VERSION 1.2 Toshiba America Medical Systems, In.C IYN Class II 2009-12-04
K093247 MEDSYNAPSE PACS SOFTWARE Medsynaptic Private, Ltd. LLZ Class II 2009-12-02
K093313 SYNERGY Topcon Medical Systems, Inc. NFJ Class II 2009-12-02
K092639 INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP GE Medical Systems SCS LLZ Class II 2009-12-02
K091934 IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300 Veran Medical Technologies, Inc. JAK Class II 2009-12-02
K093531 ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medi Cal Solutions, Inc. IYN Class II 2009-12-01
K093146 IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 Veran Medical Technologies, Inc. JAK Class II 2009-11-30
K092871 TRILOGY MX Varian Medical Systems, Inc. IYE Class II 2009-11-30
K092439 CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF Virtual Imaging, Inc. OWB Class II 2009-11-30
K092230 MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 Time Medical Limited LNH Class II 2009-11-25
K093348 3.0T 16 CHANNEL HEAD NECK SPINE COIL Ge Healthcare Coils (Usa Instruments, Inc.) MOS Class II 2009-11-25
K090584 INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS Carl Zeiss Surgical GmbH JAD Class II 2009-11-24
K093462 SONIX ULTRASOUND SCANNER Ultrasonix Medical Corporation ITX Class II 2009-11-20
K093488 ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYO Class II 2009-11-20
K092522 ACU007S Oncology Systems, Inc. KXK Class II 2009-11-20
K093291 VARIAN INTERSTITIAL TITANIUM NEEDLES Varian Medical Systems, Inc. JAQ Class II 2009-11-17
K092271 GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 GE Healthcare IYN Class II 2009-11-17
K093423 LUNGPOINT PROCEDURE PLANNING Broncus Technologies, Inc. LLZ Class II 2009-11-17
K092619 ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER Civco IYO Class II 2009-11-13
K091752 VIZTEK WL Viztek, Inc. KPR Class II 2009-11-12
K092741 COLOR LCD MONITOR, MODEL RADIFORCE MX241W Eizo Nanao Corporation LLZ Class II 2009-11-10
K092899 OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 Ningbo Xingaoyi Magnetism Co., Ltd. LNH Class II 2009-11-10
K092858 SAFERSONIC SONOGRAPHY COVER Safersonic Medizinprodukte GmbH ITX Class II 2009-11-10
K090578 SHIMADZU COLLIMATOR R-30H Shimadzu Corp. IZW Class II 2009-11-06
K092954 CADSTREAM VERSION 5 Confirma, Inc. LLZ Class II 2009-11-06
K092669 DX-D IMAGING PACKAGE Agfa Healthcare N.V. MQB Class II 2009-11-06
K092822 CAPRI APPLICATOR Vivaray, Inc. JAQ Class II 2009-11-03
K092581 MITS DICOM GATEWAY AND IMAGE MANAGER Mitsmed Medical Instrument Technology Co., Ltd. LLZ Class II 2009-10-30
K093234 INTEGRATED REGISTRATION GE Medical Systems SCS LLZ Class II 2009-10-30
K092717 DIRECT DIGITIZER, REGIUS MODEL 210 Konica Minolta Medical & Graphic, Inc. MQB Class II 2009-10-30
K092280 CYPHER DICOM PRINT SOLUTION Virtual Imaging, Inc. LMC Class II 2009-10-16
K092691 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ITX Class II 2009-10-15
K092747 PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL Philips Medical Systems (Cleveland), Inc. JAK Class II 2009-10-09
K092948 APLIO MX SSA-780A, VERSION 1.0 Toshiba America Medical Systems, In.C IYN Class II 2009-10-09
K092939 PATLOG 2.0 Oncolog Medical QA AB IYE Class II 2009-10-09
K092962 CAROTID COIL 5000004901 Shanghai Chenguang Medical Technologies Co, Ltd. MOS Class II 2009-10-09
K092182 VOYAGER COMPACT IMAGING SYSTEM Ardent Sound, Inc. IYO Class II 2009-10-09
K090991 COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO E-Woo Technology JAK Class II 2009-10-09
K092949 IMAGEGRID RADIOLOGY VIEWER SYSTEM Candelis, Inc. LLZ Class II 2009-10-08
K092204 PMD VIEWER Spencer Technologies LLZ Class II 2009-10-08
K092253 MODIFICATION TO FMRI HARDWARE SYSTEM Nordicneurolab LNH Class II 2009-10-08
K092804 MICROSELECTRON HDR V2, MODEL 105.999 Nucletron Corp. JAQ Class II 2009-10-08
K091918 ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO Genoray Co., Ltd. OWB Class II 2009-10-07
K092058 SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 2009-10-02
K092471 MODEL SENTINELLA 102 General Equipment For Medical Imaging, S.A. IYX Class I 2009-10-02
K092041 STELLAR FIDUCIAL MARKER, MODEL GFMIA Stellar Medical, LLC IYE Class II 2009-10-02
K092756 GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM Ge Vingmed Ultrasound AS ITX Class II 2009-09-28
K091828 SHEATHESISO ULTRASOUND TRANSDUCER COVER Sheathing Technologies, Inc. ITX Class II 2009-09-28
K092637 PACSCAN PLUS, MODELS 300P AND 300AP Sonomed, Inc. ITX Class II 2009-09-24
K092132 XIO RTP SYSTEM Computerized Medical Systems, Inc. MUJ Class II 2009-09-24

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