meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2012-12-18

Clearances · page 57 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K123564 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE Healthcare IYN Class II 2012-12-18
K121278 HERMES MEDICAL IMAGING SUITE V5.2 Hermes Medical Solutions AB KPS Class II 2012-12-18
K121498 PERCUNAV Philips Health Care JAK Class II 2012-12-14
K122840 CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 Mick Radio-Nuclear Instruments, Inc. JAQ Class II 2012-12-14
K123565 PRESTO 1000 SYSTEM Physiosonics, Inc. IYN Class II 2012-12-13
K122613 VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US Toshiba America Medical Systems, In.C LNH Class II 2012-12-13
K123492 DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) Philips Medical Systems MOS Class II 2012-12-13
K123503 DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2012-12-13
K123230 MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc. IYE Class II 2012-12-12
K113394 MAVRIC SL Ge Medical Systems, LLC LNH Class II 2012-12-11
K122018 OP300 Palodex Group OY OAS Class II 2012-12-10
K120282 CARDNAV Paieon, Inc. OWB Class II 2012-12-10
K123152 VITESSE 3.0 Varian Medical Systems, Oncology Systems MUJ Class II 2012-12-07
K123005 DDRVERSA MOTION Swissray Medical AG MQB Class II 2012-12-07
K122034 MRJ 3300 Paramed S.R.L. LNH Class II 2012-12-06
K123622 ACUSON Siemens Medical Solutions USA, Inc. IYN Class II 2012-12-05
K121663 CLARITY Elekta , Ltd. IYE Class II 2012-12-05
K123226 LESSRAY Saferay Spine, LLC OWB Class II 2012-12-05
K123137 CALYPSO SYSTEM Varian Medical Systems IYE Class II 2012-12-05
K120995 ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT Erad, Inc. LLZ Class II 2012-12-03
K122495 PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR Perkinelmer, Inc. MQB Class II 2012-11-28
K122429 VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL Object Research Systems (Ors), Inc. LLZ Class II 2012-11-28
K123015 .DECIMAL PHOTON BLOCK .Decimal, Inc. IXI Class II 2012-11-21
K121963 PLANMED NUANCE DIGIGUIDE Planmed OY MUE Class II 2012-11-21
K122606 PHT-6500; PHT-60CFO; PAX-I3D Mtechgroup OAS Class II 2012-11-20
K123375 SYNGO.VIA Siemens AG LLZ Class II 2012-11-20
K121499 FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM Fujifilm Medical System U.S.A., Inc. IZF Class II 2012-11-20
K122454 FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION Fujifilm Medical System U.S.A., Inc. KPR Class II 2012-11-20
K123174 CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE Healthcare LLZ Class II 2012-11-16
K113344 STEREOS WORKSTATION Eos Imaging LLZ Class II 2012-11-16
K121792 NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM Neusoft Medical Systems Co., Ltd. JAK Class II 2012-11-16
K122174 PEDIATRIC POSITIONER PAD SET Ge Healthcare Coils (Usa Instruments, Inc.) KXH Class I 2012-11-16
K122236 VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER Varian Medical Systems, Inc. JAQ Class II 2012-11-16
K123068 OPTIMA MR 430S Ge Medical Systems, LLC LNH Class II 2012-11-13
K121434 SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO Siemens Medi Cal Solutions, Inc. LNH Class II 2012-11-05
K121213 VITREAADVANCED Vital Images, Inc. LLZ Class II 2012-11-02
K122938 FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH Carl Zeiss Meditec, AG NFJ Class II 2012-11-02
K122646 DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T Invivo Corporation MOS Class II 2012-11-02
K121200 FLIGHTPLAN FOR LIVER GE Healthcare LLZ Class II 2012-11-02
K123185 DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2012-11-02
K120796 SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER Superdimension, Inc. JAK Class II 2012-10-26
K121781 ECHONAVIGATOR RELEASE 1 Philips Medical Systems Nederland B.V. LLZ Class II 2012-10-26
K122137 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated IYE Class II 2012-10-26
K123001 ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2012-10-26
K122694 GE 8CH FOOT ANKLE COIL Ge Hangwei Medical Systems Co., Ltd. MOS Class II 2012-10-25
K122289 IMAGE-COM 5.0 Tomtec Imaging Systems GmbH LLZ Class II 2012-10-24
K122241 IMAGEN3D Cardiovascular Imaging Technologies KPS Class II 2012-10-24
K121657 PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR Proton Systems IYE Class II 2012-10-23
K122523 CARESTREAM VUE PACS Carestream Health, Inc. LLZ Class II 2012-10-23
K122173 DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC Rayence Co., Ltd. MQB Class II 2012-10-19
K121845 SDX SYSTEM Dyn'R Sas IYE Class II 2012-10-19
K121564 ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 Olympus Medical Systems Corp. IYN Class II 2012-10-16
K122574 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 Edan Instruments, Inc. IYO Class II 2012-10-12
K121076 ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE Toshiba America Medical Systems, In.C LLZ Class II 2012-10-09
K122842 RADREX-I, SW V4.00 MODEL DRAD-3000E Toshiba America Medical Systems, In.C MQB Class II 2012-10-09
K122843 MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR Prodigy Technology Consultant Co., Ltd. LLZ Class II 2012-10-05
K122589 DFP4343C7 Mdi Consultants, Inc. KPR Class II 2012-10-05
K122697 PORTA 100HF Job Corporation IZL Class II 2012-10-05
K122921 C1-6-D ULTRASOUND TRANSDUCER GE Healthcare ITX Class II 2012-10-05
K121716 TBS INSIGHT Medimaps Group SA KGI Class II 2012-10-05
K122009 AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER Panasonic Healthcare Co., Ltd. IYN Class II 2012-10-03
K122450 MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS Mitsubishi Heavy Industries, Ltd. IYE Class II 2012-10-03
K122114 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE Healthcare IYN Class II 2012-10-03
K122451 EXACTRAC VERO Brainlab AG IYE Class II 2012-09-28
K122825 ACUSON Siemens Medical Solutions USA, Inc. IYN Class II 2012-09-28
K122022 ATHEROEDGE Atheropoint, LLC LLZ Class II 2012-09-26
K113483 ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION Philips Healthcare (Cleveland) JAK Class II 2012-09-26
K122341 PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 Hitachi Aloka Medical, Ltd. IYN Class II 2012-09-26
K122638 TOSHIBA 3T 32CH HEAD SPEEDER COIL, Quality Electrodynamics MOS Class II 2012-09-25
K122428 FAXITRON SPECIEN RADIOGRAPHY SYSTEM Faxitron Bioptics, LLC MWP Class II 2012-09-25
K121674 ASPIRE HD PLUS, ASPIRE HD-S Fujifilm Medical System U.S.A., Inc. MUE Class II 2012-09-21
K122026 PRISM ACQUIRE PRISM PROCESS PRISM VIEW Prism Clinical Imaging, Inc. LNH Class II 2012-09-21
K122109 AQUILION ONE VISION, V4.90 Toshiba America Medical Systems, In.C JAK Class II 2012-09-21
K122327 VOLUSON E6/E8/E8EXPERT/E10 GE Healthcare IYN Class II 2012-09-21
K111142 ECHOSOFT(TM) Echometrix, LLC LLZ Class II 2012-09-21
K121729 E-CUBE 7 Alpinion Medical Systems Co., Ltd. IYN Class II 2012-09-20
K121676 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT Ge Medical Systems, LLC LNH Class II 2012-09-20
K121689 VITASCAN LT SCANMASTER Vitacon Medical, Inc. IYO Class II 2012-09-19
K120288 ORTHOCAD SOFTWARE OPTION Esaote, S.p.A. LLZ Class II 2012-09-19
K121479 AIM Inneroptic Technology, Inc. IYO Class II 2012-09-13
K122119 DX-D FULL LEG FULL SPINE Afga Healthcare N.V. KPR Class II 2012-09-13
K122413 PATIENT POSITIONING SYSTEM Forte Automation Systems, Inc. JAI Class II 2012-09-13
K113725 VIRTUOST O.N. Diagnostics KGI Class II 2012-09-13
K122491 VIAMO SSA-640A V4.0 Toshibamedical Systems Corporation IYN Class II 2012-09-13
K121827 GSI VIEWER WITH VUE OPTION GE Medical Systems SCS JAK Class II 2012-09-13
K122427 CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE Carestream Dental, LLC LLZ Class II 2012-09-12
K122260 AYCAN MOBILE Aycan Digitalsysteme GmbH LLZ Class II 2012-09-12
K122515 C2-9-D ULTRASOUND TRANSDUCER GE Healthcare ITX Class II 2012-09-11
K122387 VOLUSON P6, VOLUSON P8 GE Healthcare IYN Class II 2012-09-11
K122471 SOMATOM DEFINITION Siemens Medical Systems, Inc. JAK Class II 2012-09-11
K122136 VITREAVIEW Vital Images, Inc. LLZ Class II 2012-09-07
K121983 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA Benq Medical Technology Corpation IYN Class II 2012-09-07
K122164 MR VESSELLQ XPRESS GE Medical Systems SCS LLZ Class II 2012-09-07
K122583 UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2012-09-05
K122201 PROTURA COUCH SOFTWARE Med-Tec, Inc. D/B/A Civco Medical Solutions JAI Class II 2012-08-30
K121311 THIXO-GEL ULTRASOUND SPRAY Cloverline International Pharma Services GmbH MUI Class II 2012-08-30
K121934 TOMOTHERAPY TREATMENT SYSTEM Accuray Incorporated IYE Class II 2012-08-29
K120246 KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) Carestream Health, Inc. MUE Class II 2012-08-28
K120629 FDR GO FLEX Fujifilm Medical System U.S.A., Inc. MQB Class II 2012-08-28
K121400 PAX-UNI3D, PHT-7500 VATECH Co., Ltd. OAS Class II 2012-08-28

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