meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2014-04-28

Clearances · page 52 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133580 ARTIS ONE Siemens Medical Solutions USA, Inc. OWB Class II 2014-04-28
K140677 MYLABSSOGNO Esaote, S.p.A. IYN Class II 2014-04-25
K140834 TERASON USMART3400 ULTRASOUND SYSTEM Teratech Corp. IYN Class II 2014-04-25
K140771 PHILIPS ELEVA WORKSPOT Philips Medical Systems Dmc GmbH MQB Class II 2014-04-25
K133278 DISCOVERY IGS 740 GE Medical Systems SCS OWB Class II 2014-04-24
K140445 DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC Imaging Sciences International, LLC LLZ Class II 2014-04-23
K133761 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 Toshibamedical Systems Corporation IYN Class II 2014-04-22
K133649 HEPATIC VCAR GE Medical Systems SCS JAK Class II 2014-04-22
K133922 GENTLECARE AR APPLICATOR Gc Medtech, LLC JAQ Class II 2014-04-18
K133589 SOMATOM FORCE Siemens Medical Solutions USA, Inc. JAK Class II 2014-04-17
K140808 Q-STATION Philips Ultrasound, Inc. LLZ Class II 2014-04-17
K133524 PVMED DDR 2430T Portavision Medical, LLC MQB Class II 2014-04-16
K140639 PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM Hitachi Aloka Medical, Ltd. IYN Class II 2014-04-16
K133905 6200 / 6250 ULTRASOUND SYSTEM Esaote, S.p.A. IYN Class II 2014-04-15
K133781 DECLIPSESPECT LAPAROSCOPY Surgiceye GmbH IZD Class I 2014-04-11
K140646 DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G Rayence Co., Ltd. MQB Class II 2014-04-11
K133705 REVOLUTION CT Ge Medical Systems, LLC JAK Class II 2014-04-11
K133521 AZE PHOENIX SOFTWARE Aze, Ltd. LLZ Class II 2014-04-11
K132934 MULTIX SELECT DR Siemens Medi Cal Solutions, Inc. KPR Class II 2014-04-10
K132902 SYNGO DUAL ENERGY SOFTWARE PACKAGE Siemens Medical Solutions USA, Inc. JAK Class II 2014-04-07
K132381 CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT Clearmri Solutions, Inc. LNH Class II 2014-04-04
K133572 ARIA RADIATION THERAPY MANAGEMENT Varian Medical Systems, Inc. IYE Class II 2014-04-04
K133910 NORDICBRAINEX Nordicneurolab LLZ Class II 2014-04-04
K140702 8MP COLOR LCD MONITOR, RADIFORCE RX850 Eizo Corporation PGY Class II 2014-04-04
K133139 VIZION ULTRA Viztek, LLC MQB Class II 2014-04-03
K133914 VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE Medcom GmbH LHN Class II 2014-04-03
K130757 KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET Spencer Fillmore JAQ Class II 2014-04-03
K140271 TABLET VIEWER SOFTWARE FOR IMAGE SUITE Carestream Health, Inc. LLZ Class II 2014-04-01
K140199 VUPAD Sonomed, Inc. IYO Class II 2014-04-01
K131075 X-RAY TV SYSTEM SONIAL VISION G4 Shimadzu Corp. JAA Class II 2014-03-28
K122298 AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR Ajex Meditech., Ltd. IZL Class II 2014-03-28
K133174 ORTHOSCAN FD MINI C-ARM Orthoscan, Inc. OXO Class II 2014-03-28
K133984 CORONIS 5MP Barco N.V. LLZ Class II 2014-03-28
K134016 ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical IYN Class II 2014-03-28
K133719 PDE-NEO Hamamatsu Photonics K.K. IZI Class II 2014-03-27
K133508 RESOLUTIONMD MOBILE Calgary Scientific, Inc. LLZ Class II 2014-03-26
K133544 OP300 Palodex Group OY OAS Class II 2014-03-26
K133640 ASIR-V Ge Medical Systems, LLC JAK Class II 2014-03-25
K133972 ASPIRE CRISTALLE Fujifilm Medical Systems U.S.A, Inc. MUE Class II 2014-03-25
K133993 CAAS WORKSTATION Pie Medical Imaging IZI Class II 2014-03-25
K133663 NIO COLOR 2MP Barco N.V. LLZ Class II 2014-03-25
K140524 TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM Teratech Corp. IYN Class II 2014-03-21
K133782 NOVA FA DR SYSTEM Sedecal., Sa. MQB Class II 2014-03-21
K133657 DISCOVERY PET/CT 710 Ge Medical Systems, LLC KPS Class II 2014-03-21
K140253 MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE Siemens Medical Solutions USA, Inc. LNH Class II 2014-03-20
K133209 FORESEE (4C) IMAGING SYSTEM Diagnostic Photonics, Inc. NQQ Class II 2014-03-17
K132944 ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION Ge Hungary Kft KPQ Class II 2014-03-14
K133227 SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING Varian Medical Systems, Inc. IYE Class II 2014-03-14
K133323 VOLCANO IFR MODALITY Volcano Corporation IYO Class II 2014-03-14
K134052 RADIANCE 330 PROTON THERAPY SYSTEM Protom International, Inc. LHN Class II 2014-03-14
K133406 CS 8100 3D Trophy OAS Class II 2014-03-14
K133442 BONE SUPPRESSION SOFTWARE Carestream Health, Inc. MQB Class II 2014-03-11
K132736 ACCURO 3000 ULTRASOUND SCANNER Rivanna Medical, LLC IYO Class II 2014-03-11
K132094 CIOS ALPHA Siemens Medi Cal Solutions, Inc. OWB Class II 2014-03-11
K131433 ISYS 1 (U.S),ACCESSORY, NON-STERILE Isys Medizintechnik GmbH JAK Class II 2014-03-11
K133401 SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL Siemens Medical Solutions USA, Inc. LLZ Class II 2014-03-11
K133135 IMPAX VOLUME VIEWING 3.0 Agfa Healthcare N.V. LLZ Class II 2014-03-07
K140291 VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS Volcano Corporation IYO Class II 2014-03-07
K140093 TABLE Anatomage, Inc. LLZ Class II 2014-03-07
K133966 MODEL-BASED RSA SOFTWARE Halifax Biomedical, Inc. LLZ Class II 2014-03-06
K140153 VENTRIPOINT MEDICAL SYSTEM Ventripoint, Inc. IYN Class II 2014-03-06
K133022 ZEDVIEW Lexi Co., Ltd. LLZ Class II 2014-03-06
K133292 ALLURA XPER FD; OR TABLE Philips Medical Systems Nederland B.V. OWB Class II 2014-03-05
K132908 TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT Medtec, Inc. IYE Class II 2014-03-04
K140126 SONIC WINDOW Analogic Corporation IYO Class II 2014-03-04
K133937 HEARTSCAN SOFTWARE Morpheus Imaging, Inc. LLZ Class II 2014-03-03
K132800 SKINTELL Agfa Healthcare N.V. NQQ Class II 2014-03-03
K131896 SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM Suzhou Anke Medical System Co., Ltd. LNH Class II 2014-02-28
K133609 THE DOME S6C Nds Surgical Imaging LLZ Class II 2014-02-28
K132064 BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. IYE Class II 2014-02-28
K132763 ADVANCED VIEWER Brainlab AG LLZ Class II 2014-02-28
K131777 HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM Hyper Technology, Inc. IWB Class II 2014-02-28
K133654 SCENIUM Siemens Medical Solutions USA, Inc. LLZ Class II 2014-02-28
K140033 TARGET3D FUSION Convergent Life Sciences, Inc. LLZ Class II 2014-02-27
K133385 LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE Broncus Medical, Inc. LLZ Class II 2014-02-26
K140282 ST SENSE NV 8 ARRAY COIL Resonance Innovations, LLC MOS Class II 2014-02-26
K132889 FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM) Nucletron B.V. JAQ Class II 2014-02-26
K123508 TRINIAS Shimadzu Corporation OWB Class II 2014-02-26
K140254 EZONO 4000 Ezono AG IYN Class II 2014-02-26
K133320 SICAT FUNCTION Sicat GmbH & Co. KG LLZ Class II 2014-02-25
K132690 UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM Qisda Corporation IYN Class II 2014-02-25
K133644 SYNGO.VIA MI WORKFLOWS Siemens Medical Solutions USA, Inc. LLZ Class II 2014-02-25
K132935 ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME Siemens Medical Solutions USA, Inc. IYE Class II 2014-02-21
K132874 LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM Nucletron B.V. JAQ Class II 2014-02-21
K133409 DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA Rayence Co., Ltd. MQB Class II 2014-02-21
K132842 FLAATZ 600 SERIES (FLAATZ 600/601) Drtech Corp. MQB Class II 2014-02-21
K140030 DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2014-02-19
K140214 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) Jvckenwood Corporation LLZ Class II 2014-02-19
K140103 3MP GRAYSCAKE LCD DISPLAY Shenzhen Beacon Display Technology Co., Ltd. LLZ Class II 2014-02-14
K133708 MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR Nec Display Solutions , Ltd. LLZ Class II 2014-02-14
K140108 3MP COLOR LCD DISPLAY Shenzhen Beacon Display Technology Co., Ltd. LLZ Class II 2014-02-14
K133526 MDIXON-QUANT Philips Medical Systems Nederland B.V. LNH Class II 2014-02-12
K133533 LOGIQ E GE Healthcare IYN Class II 2014-02-12
K133497 AQUILION ONE VISION Toshibamedical Systems Corporation JAK Class II 2014-02-10
K133692 IMRI 1.5T AND IMRI 3T S Imris, Inc. LNH Class II 2014-02-10
K133247 ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. MUJ Class II 2014-02-07
K132824 CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION Carestream Health, Inc. LLZ Class II 2014-02-06
K132813 DUAL ENERGY SYSTEM PACKAGE Toshibamedical Systems Corporation JAK Class II 2014-02-06
K133730 CO PILOT/REGIUS UNITEA Konica Minolta, Inc. LLZ Class II 2014-01-31
K133655 RADIANCE V2 Gmv Soluciones Globales Internet S.A.U. MUJ Class II 2014-01-31

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