meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
24
Latest Decision
2014-11-12

Clearances · page 50 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K141038 ANT MODEL 1 Advanced Nuclide Technologies, LLC KXK Class II 2014-11-12
K142517 SoftVue Delphinus Medical Technologies, Inc. IYO Class II 2014-10-31
K141745 IQQA-BODYIMAGING SOFTWARE Edda Technology LLZ Class II 2014-10-31
K141881 RAPIDRESULTS Ramsoft, Inc. LLZ Class II 2014-10-31
K141570 IMPLANT STUDIO 3Shape Medical A/S LLZ Class II 2014-10-31
K132853 NOVAPACS Novarad Corp. LLZ Class II 2014-10-30
K142443 Site-Rite 6 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc. IYO Class II 2014-10-30
K141539 KUBTEC X250 Kub Technologies, Inc. IZL Class II 2014-10-29
K142733 E-CUBE 5 Alpinion Medical Systems Co., Ltd. IYN Class II 2014-10-28
K141459 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 Toshibamedical Systems Corporation IYN Class II 2014-10-28
K142884 E-CUBE 12 Alpinion Medical Systems Co., Ltd. IYN Class II 2014-10-28
K131737 SUPERNOVA C5 MRI SYSTEM Liaoning Kampo Medical System Co., Ltd. LNH Class II 2014-10-23
K142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. IYN Class II 2014-10-23
K141860 RAYSTATION Raysearch Laboratories AB MUJ Class II 2014-10-23
K142755 Siemens 3.0 Blanket Array Coil Resonance Innovations, LLC MOS Class II 2014-10-23
K142698 PerkinElmer, XRpad 4343 F MED Flat Panel Detector Perkinelmer, Inc. MQB Class II 2014-10-23
K142708 VERADIUS UNITY Philips Medical Systems Nethrlands BV OWB Class II 2014-10-22
K140251 UNIVERSAL DIGITAL INTERFACE 2, UDI 2 Meridian Medical Systems, LLC MQB Class II 2014-10-22
K142003 FDR D-EVO II FLAT PANEL DETECTOR SYSTEM Fujifilm Medical System U.S.A., Inc. MQB Class II 2014-10-21
K133677 SYNGO CT SINGLE SOURCE DUAL ENERGY Siemens Medical Solutions USA, Inc. JAK Class II 2014-10-16
K142618 Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System Hitachi Aloka Medical America, Inc. ITX Class II 2014-10-16
K142184 DX-D IMAGING PACKAGE Agfa Healthcare N.V. MQB Class II 2014-10-16
K142160 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE Healthcare IYN Class II 2014-10-10
K142037 QUANTRA Hologic, Inc. LLZ Class II 2014-10-10
K142628 Acuson SC2000 Diagnostic Ultrasound System Siemens Medi Cal Solutions, Inc. IYN Class II 2014-10-10
K142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System Ge Medical Systems Israel , Ltd. IYN Class II 2014-10-10
K141855 CLARITY Elekta , Ltd. IYE Class II 2014-10-08
K142515 MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra Siemens Medical Solutions USA, Inc. LNH Class II 2014-10-08
K142466 UGEO PT60A Diagnostic Ultrasound System Samsung Medison Co., Ltd. IYN Class II 2014-10-03
K142536 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) Jvckenwood Corporation PGY Class II 2014-10-03
K141743 FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT Radiology Solutions, LLC MQB Class II 2014-10-03
K142540 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) Jvckenwood Corporation PGY Class II 2014-10-03
K141297 FORUM GLAUCOMA WORKPLACE Carl Zeiss Meditec, AG NFJ Class II 2014-10-03
K141765 FDR D-EVO FLAT PANEL DETECTOR SYSTEM Fujifilm Medical Systems U.S.A, Inc. MQB Class II 2014-10-03
K142268 Varian Verification System (VVS) Varian Medical Systems, Inc. IYE Class II 2014-10-02
K142054 IMACOR ZURA EVO IMAGING SYSTEM Imacor, Inc. IYO Class II 2014-09-29
K140380 OPERA SWING General Medical Merate S.P.A JAA Class II 2014-09-26
K142085 DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T Ge Medical Systems, LLC LNH Class II 2014-09-26
K141490 UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET Varian Medical Systems, Inc. JAQ Class II 2014-09-26
K141271 AERODR SYSTEM 2 Konica Minolta, Inc. MQB Class II 2014-09-26
K141800 PERFRACTION Sun Nuclear Corporation IYE Class II 2014-09-26
K133603 PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION Philips Medical Systems JAK Class II 2014-09-25
K142383 Optima XR200amx, Optima XR220amx Ge Medical Systems, LLC IZL Class II 2014-09-25
K141669 SURGIMAP Nemaris, Inc. LLZ Class II 2014-09-19
K141806 CLEAR GUIDE ONE Clear Guide Medical IYO Class II 2014-09-19
K141472 VANTAGE ELAN Toshiba America Medical Systems, In.C LNH Class II 2014-09-19
K141885 CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY Minxray, Inc. IZL Class II 2014-09-18
K140399 EBM IDO VIEWER Ebm Technologies USA, LLC LLZ Class II 2014-09-18
K141477 DISCOVERY IQ Ge Medical Systems, LLC KPS Class II 2014-09-18
K141607 DENTAL IMAGING SOFTWARE Trophy LLZ Class II 2014-09-18
K142325 Veenstra Instruments VDC-506 Dose Calibrator Comecer Netherlands B.V. KPT Class II 2014-09-18
K141895 MOBILEDIAGNOST WDR Sedecal., Sa. IZL Class II 2014-09-18
K141074 CORTEX ID SUITE Ge Medical Systems, LLC KPS Class II 2014-09-18
K141069 Lung Density Analysis Imbio, LLC JAK Class II 2014-09-17
K142048 EMPRINT PROCEDURE PLANNING APPLICATION Covidien, LLC LLZ Class II 2014-09-17
K141137 STEREOS WORKSTATION Eos Imaging LLZ Class II 2014-09-15
K140912 SOMATOM SCOPE/SOMATOM SCOPE POWER Siemens Medical Solutions USA, Inc. JAK Class II 2014-09-15
K142077 MYLABGAMMA Esaote, S.p.A. IYN Class II 2014-09-12
K142008 MYLABSEVEN, MYLABALPHA Esaote, S.p.A. IYN Class II 2014-09-12
K141971 BIOGRAPH TRUE PET/CT FAMILY SOFTWARE Siemens Medical Solutions USA, Inc. KPS Class II 2014-09-12
K141602 DX-D IMAGING PACKAGE Agfa Healthcare N.V. MQB Class II 2014-09-12
K142423 EyeSuite Imaging Haag-Streit AG NFJ Class II 2014-09-10
K142395 SC2000 and ACUSON X300 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. IYO Class II 2014-09-09
K141541 XIDF-AWS801, ANGIO WORKSTATION, V5.31 Toshibamedical Systems Corporation JAA Class II 2014-09-08
K141572 MOSAIQ ONCOLOGY INFORMATION SYSTEM Impac Medical Systems, Inc. IYE Class II 2014-09-05
K133324 SURESUBTRACTION LUNG Toshiba Medical Systems Corporation, Japan JAK Class II 2014-09-05
K141574 ARTIS ZEE/ZEEGO SW VC21 Siemens Medical Solutions USA, Inc. OWB Class II 2014-09-05
K141248 SMART SEGMENTATION KNOWLEDGE BASED CONTOURING Varian Medical Systems, Inc. MUJ Class II 2014-09-05
K141343 AXXENT CERVICAL APPLICATOR Icad, Inc. JAD Class II 2014-09-05
K134025 AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT Toshibamedical Systems Corporation JAK Class II 2014-09-05
K140528 TRUE BEAM, TRUE BEAM STX, EDGE Varian Medical Systems, Inc. IYE Class II 2014-09-05
K133797 QMASTER-H/REVO Telesystems Co., Ltd. OAS Class II 2014-09-04
K141514 SYNAPSE 3D TENSOR ANALYSIS Fujifilm Meidcal Systems U.S.A.,Inc. LLZ Class II 2014-09-03
K140342 QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT Mindways Software, Inc. KGI Class II 2014-08-29
K140490 CIVA SHEET PD-103 Civatech Oncology, Inc. KXK Class II 2014-08-29
K141364 CLIMB MAMMOGRAPHY VIEWER SOFTWARE Climb Medical Systems, Inc. LLZ Class II 2014-08-29
K141440 DICOMPACS DX-R WITH FLAT PANEL Oehm Und Rehbein GmbH MQB Class II 2014-08-29
K141435 OPAL CHIRO, 20/20 P-DR 2020 Imaging MQB Class II 2014-08-27
K141230 DOSELAB PRO Mobius Medical Systems, LP IYE Class II 2014-08-27
K141451 VixWin Platinum Imaging Sciences International (Dba Gendex, LLC) LLZ Class II 2014-08-26
K142017 X-PORTE ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. IYN Class II 2014-08-22
K141480 CVI42 Circle Cardiovascular Imaging, Inc. LLZ Class II 2014-08-22
K142002 BREAST SPEEDER CX, GRID HOLDER CX Quality Electrodynamics, LLC MOS Class II 2014-08-22
K142006 SYMBIA 6.0 Siemens Medical Solutions USA, Inc. KPS Class II 2014-08-21
K140723 NOMAD MD 75K V HANDHELD X-RAY SYSTEM Aribex, Inc. IZL Class II 2014-08-19
K141136 LEICA FL800 Leica Biosystems Richmond IZI Class II 2014-08-19
K141979 ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES Philips Medical Systems Netherland BV OWB Class II 2014-08-19
K140232 SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT Siemens Medical Solutions USA, Inc. JAK Class II 2014-08-14
K140956 LCD MONITOR Nordicneurolab LNH Class II 2014-08-07
K141846 ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2014-08-07
K133695 TITAN 11 Gemss Medical Systems Co., Ltd. KPR Class II 2014-08-07
K141283 ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. MUJ Class II 2014-08-07
K132983 TON-95LH, PAX-I3D ORTHO VATECH Co., Ltd. OAS Class II 2014-08-07
K141787 SAGITTILT Orfit Industries NV IYE Class II 2014-08-07
K141870 BREAST VOLUME NAVIGATOR Metritrack, LLC IYN Class II 2014-08-07
K141336 SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS Varian Medical Systems, Inc. JAQ Class II 2014-08-06
K133506 NORAS OR HEAD HOLDER FLEXIBILITY Noras Mri Products GmbH MOS Class II 2014-08-06
K131348 ORTOMED Infomed Servicios Informaticos S.L. LLZ Class II 2014-08-05
K141768 LOGIQ V5/LOGIQ V3 GE Healthcare IYN Class II 2014-08-04
K141891 MEDICAL LCD MONITOR Kostec Co., Ltd. PGY Class II 2014-08-04

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