meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
21
Latest Decision
2008-03-10

Clearances · page 72 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K080422 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 Eizo Nanao Corporation LLZ Class II 2008-03-10
K080120 HFO SHOULDER COIL Philips Medical Systems MR Finland MOS Class II 2008-03-10
K080098 MRJ EXTENDED Paramed S.R.L. LNH Class II 2008-03-10
K073062 OMNI-VUE SYSTEM Genesis Digital Imaging, Inc. LLZ Class II 2008-03-10
K073156 QPLAQUE MR Medis Medical Imaging Systems BV LNH Class II 2008-03-04
K072683 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM Xoft, Inc. JAD Class II 2008-02-29
K080176 ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM Aloka Co., Ltd. IYN Class II 2008-02-29
K073418 SYNGO IMAGING CCF VA10A Siemens AG Medical Solutions LLZ Class II 2008-02-29
K073138 CARDIQ EXPRESS VERSION 2.0 GE Medical Systems JAK Class II 2008-02-26
K073153 CARDIQ FUNCTION XPRESS GE Medical Systems SCS JAK Class II 2008-02-26
K080333 IMAGEGRID Candelis, Inc. LLZ Class II 2008-02-22
K080290 XVIEWNET American Radiologist Network, Inc. LLZ Class II 2008-02-22
K080334 INSTARAD Medsphere Technologies Pvt , Ltd. LLZ Class II 2008-02-21
K080119 CLEARSCAN Esi, Inc. ITX Class II 2008-02-21
K073704 I-DIXEL J. Morita USA, Inc. LLZ Class II 2008-02-21
K080320 PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 Nds Surgical Imaging LLZ Class II 2008-02-21
K072821 VITREA 4DCT Vital Images, Inc. LLZ Class II 2008-02-20
K080234 TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO Teratech Corp. IYO Class II 2008-02-14
K073007 CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL Barcoview, Medical Imaging Systems LLZ Class II 2008-02-14
K073194 CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS Cardiovascular Imaging Solutions , Ltd. LLZ Class II 2008-02-14
K080062 OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 Hitachi Medical Systems America, Inc. MOS Class II 2008-02-11
K073290 ARTIS ZEE AND ZEEGO Siemens Medical Solutions USA, Inc. IZI Class II 2008-02-11
K071794 15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2) Totoku Electric Co., Ltd. LLZ Class II 2008-02-11
K080160 APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM Toshiba America Medical Systems, In.C IYN Class II 2008-02-08
K073003 SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY Siemens Medi Cal Solutions, Inc. JAK Class II 2008-02-07
K080048 MSK EXTREME MR SCANNER, MODEL AA5000 Oni Medical Systems, Inc. LNH Class II 2008-02-06
K073650 FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 Fujifilm Medical Systems U.S.A, Inc. KPR Class II 2008-02-06
K073457 MSTAR MPD4500 Xinaomdt Technology Co., Ltd. LNH Class II 2008-02-01
K080124 VENTRI 1.1 Ge Medical Systems F.I. Haifa KPS Class II 2008-01-31
K073670 KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 Orex Computed Radiography, Ltd. MQB Class II 2008-01-25
K072653 3VISEON/SURGERY 3Mensio Medical Imaging BV LLZ Class II 2008-01-24
K080049 VASCUVIEW ULTRASOUND SYSTEM Escalon Medical Corp. IYO Class II 2008-01-23
K073018 STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT Brainlab AG IYE Class II 2008-01-23
K080064 FLAATZ 750 Drtech Corp. MQB Class II 2008-01-23
K080004 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM Sicel Technologies, Inc. NZT Class II 2008-01-23
K080038 VANTAGE TITAN, MODEL MRT-1504/S3 Toshiba America Medical Systems, In.C LNH Class II 2008-01-22
K072875 NIO 5MP DISPLAY, MODEL E5620 Barcoview, Medical Imaging Systems LLZ Class II 2008-01-22
K073292 MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM Heeyoung Co., Ltd. LLZ Class II 2008-01-18
K073310 OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL Hitachi Medical Corp. MOS Class II 2008-01-18
K073131 MICROMRI WRIST COIL Micromri, Inc. MOS Class II 2008-01-18
K073114 IMIX INSIGHT X-RAY SYSTEMS Imix Adr Finland OY KPR Class II 2008-01-17
K080013 REGISTRATION AND FUSION Agfa Healthcare Corporation LLZ Class II 2008-01-17
K073088 SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc. IZI Class II 2008-01-10
K073632 INTUITION, MODEL 0170 Arcoma AB KPR Class II 2008-01-10
K073130 SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc. IZI Class II 2008-01-10
K071287 ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO Shimadzu Medical Systems ITX Class II 2008-01-09
K071289 ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO Shimadzu Medical Systems ITX Class II 2008-01-09
K073169 SCIMAGE PICOMENTERPRISE Scimage, Inc. LLZ Class II 2008-01-09
K071291 ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 Shimadzu Medical Systems ITX Class II 2008-01-09
K073306 XORANCONNECT Xoran Technologies, Inc. LLZ Class II 2008-01-07
K073167 BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER Ge Medical Systems, LLC LNH Class II 2008-01-04
K073238 SYNGO VOLUME PERFUSION-CT NEURO Siemens AG Medical Solutions JAK Class II 2008-01-03
K072485 ARTISTE MV SA Siemens Medical Solutions USA, Inc. IYE Class II 2007-12-27
K043617 IMAGECHECKER CT CAD SOFTWARE SYSTEM Hologic, Inc. OEB Class II 2007-12-21
K073456 T-QUEST SYSTEM Medx, Inc. IYX Class I 2007-12-20
K073259 XIDF-100A/B1 IMAGE PROCESSOR Toshiba America Medical Systems, In.C LLZ Class II 2007-12-20
K073448 MEDICAL DISPLAY, MD205MG Nec Display Solutions , Ltd. LLZ Class II 2007-12-20
K073196 MASTER-VU Sonomed, Inc. IYO Class II 2007-12-19
K073340 COLOR LCD MONITOR, FLEXSCAN MX300W Eizo Nanao Corporation LLZ Class II 2007-12-19
K073408 GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM Ge Medical Systems Ultrasound and Primary Care Dia IYN Class II 2007-12-19
K073020 ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. MUJ Class II 2007-12-19
K073205 NIO 5MP, MODEL MDNG-5121 Barcoview, Medical Imaging Systems LLZ Class II 2007-12-19
K073373 SYNGO VOLUME PERFUSION-CT BODY Siemens AG Medical Solutions JAK Class II 2007-12-18
K073297 GE LOGIQ P6 General Electric Co. IYN Class II 2007-12-18
K072676 ACUSON X300 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYO Class II 2007-12-18
K072766 PVMED DDR 2520 DIGITAL IMAGING SYSTEM Portavision Medical IXK Class II 2007-12-11
K073272 WORKSTATIONONE BREAST IMAGING WORKSTATION Three Palm Software, LLC LLZ Class II 2007-12-11
K072637 DIVO A2d Imaging, LLC LLZ Class II 2007-12-11
K073273 EQUAL DOSE 1.0 Nucletron Corporation IYE Class II 2007-12-11
K073059 PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Hitachi, Ltd., Power Systems Group LHN Class II 2007-12-10
K072473 CHASE MR SYSTEM Chase Medical, LP LNH Class II 2007-12-10
K073107 VALENCIA SKIN APPLICATOR SET, MODEL: 189.701 Nucletron Corporation JAQ Class II 2007-12-07
K072374 COMPASS Scanditronix Wellhofer GmbH IYE Class II 2007-12-07
K073271 ORTHOGON Agfa Healthcare Corporation LLZ Class II 2007-12-05
K073236 NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE Neocoil MOS Class II 2007-11-30
K072780 MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR Ralco S.R.L. IZW Class II 2007-11-26
K073181 NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL Neocoil, LLC MOS Class II 2007-11-21
K073081 JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X Toshiba America Medical Systems, In.C LNH Class II 2007-11-21
K072867 IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K Imix Adr Finland OY KPR Class II 2007-11-21
K072850 MRI SYSTEM, MODEL MAGFINDER II / AI 3200 Advanced Imaging Laboratory LNH Class II 2007-11-21
K073099 FMRI HARDWARE SYSTEM Nordicneurolab LNH Class II 2007-11-20
K072986 INTEGRADWEB PACS SYSTEM GE Healthcare LLZ Class II 2007-11-20
K072873 LBS-63-16 BREAST ARRAY COIL Invivo MOS Class II 2007-11-16
K072952 GE ECHOPAC General Electric Co. LLZ Class II 2007-11-16
K073124 COLLIMARE COLLIMATOR FAMILY Collimare, LLC IZW Class II 2007-11-16
K072874 LBS-127-16 BREAST ARRAY COIL Invivo MOS Class II 2007-11-16
K073133 INTERSTITIAL NEEDLES Varian Medical Systems, Inc. JAQ Class II 2007-11-16
K073165 DRAD-3000E, RADREX-I Toshiba America Medical Systems, In.C MQB Class II 2007-11-16
K070968 CHOY COMPRESSION FRAME Choy Medical Technologies, Inc. LNH Class II 2007-11-15
K072659 RAD VISION, MODELS E AND EU Almana Medical Imaging KPR Class II 2007-11-15
K072984 SATURN 9000-550 New Medical Co., Ltd. MQB Class II 2007-11-14
K073056 DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 Vieworks Co., Ltd. MQB Class II 2007-11-13
K072983 SATURN 9000-750 New Medical Co., Ltd. MQB Class II 2007-11-13
K072786 ACUSON S2000 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. ITX Class II 2007-11-13
K071760 MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. MUJ Class II 2007-11-09
K071619 SPY FLUORESCENT IMAGING SYSTEM Novadaq Technologies, Inc. IZI Class II 2007-11-09
K072916 TRILOGY SYSTEM WITH RAPIDARC Varian Medical Systems, Inc. IYE Class II 2007-11-09
K072960 CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET Cdp, Ltd. LLZ Class II 2007-11-08
K073021 MULTI-SPECT Eagle Heart Imaging, LLC KPS Class II 2007-11-06
K072972 MEDSTREAMING MEDICAL OFFICE SOFTWARE Medstreaming, LLC LLZ Class II 2007-11-06

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