meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2010-12-20

Clearances · page 64 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K102889 HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON Hitachi Medical Systems America, Inc. MOS Class II 2010-12-20
K100372 SAFECT MODEL VER 1.0 Medic Vision Brain Technologies, Ltd. LLZ Class II 2010-12-14
K102989 OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS Chang Gung Medical Technology Co., Ltd. Linkou Fac IYN Class II 2010-12-09
K102765 PRONEX Direx Systems Corp. IYE Class II 2010-12-07
K100837 PACENTRIC CONNECT, TRAVELER AND WEB Fimreite Software AS LLZ Class II 2010-12-03
K102587 LLX240AB01 Samsung Mobile Display Co., Ltd. MQB Class II 2010-12-01
K102599 TOMOPHASE OCTIS Tomophase Corporation NQQ Class II 2010-12-01
K101590 DIGITAL FLAT PANEL X-RAY DETECTOR VATECH Co., Ltd. MQB Class II 2010-11-29
K102349 AERODR SYSTEM Konica Minolta Medical & Graphic, Inc. KPR Class II 2010-11-24
K102237 PVS MODEL 1.0 Medcom GmbH IYE Class II 2010-11-23
K102849 ACCULMAING Radiology Information Systems, Inc. LLZ Class II 2010-11-23
K102390 SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc. IYN Class II 2010-11-19
K092728 20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) Totoku Electric Co., Ltd. LLZ Class II 2010-11-19
K100598 PENRITH ELETTRA ULTRASOUND SYSTEM Penrith Corporation IYN Class II 2010-11-19
K093891 AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 Toshibamedical Systems Corporation JAK Class II 2010-11-18
K102615 WIRELESS DR IMAGING OPTION-WDR1 Ge Medical Systems, LLC MQB Class II 2010-11-18
K102650 CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated IYE Class II 2010-11-17
K103215 CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT Cianna Medical JAQ Class II 2010-11-15
K101654 IMPROVIS IMAGING SYSTEM American Dental Partners, Inc. LLZ Class II 2010-11-10
K102344 MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS Philips Medical Systems Nederland B.V. LNH Class II 2010-11-09
K102198 COMPACT TOUCH STS Quantel Medical S.A. IYO Class II 2010-11-05
K102393 VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM Ge Medical System Israel , Ltd. IYO Class II 2010-11-05
K101220 EXPLORER 4D TREATMENT PLANNING SYSTEM American Radiosurgery, Inc. MUJ Class II 2010-11-05
K102200 INTEGRITY MODEL 1014284 Elekta , Ltd. IYE Class II 2010-11-04
K102388 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM Ge Medical System Israel , Ltd. IYN Class II 2010-11-04
K102231 DISCOVERY NM 750B Ge Medical Systems Israel, Functional Imaging IYX Class I 2010-11-03
K102865 DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. ITX Class II 2010-11-03
K102583 MUCHECK, VERSION 9.0 Oncology Data Systems, Inc. IYE Class II 2010-11-02
K101686 FDR IMAGE STITCHING OPTION Fujifilm Medical System U.S.A., Inc. KPR Class II 2010-10-29
K101707 FULACCESS MODEL 1.0 Fulcrum Medical, Inc. LLZ Class II 2010-10-29
K103050 DX-D 300 Agfa Healthcare N.V. KPR Class II 2010-10-29
K101042 BLADEVIEW Accogent, LLC KPR Class II 2010-10-29
K102901 HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. IYN Class II 2010-10-27
K102680 Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM Control-X Medical, Inc. KPR Class II 2010-10-22
K102991 M5 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYO Class II 2010-10-22
K102023 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C Shantou Institute of Ultrasonic Instruments (Siui IYN Class II 2010-10-19
K102435 BEYONDIMAGE WORKSTATION Neusoft Medical Systems Co., Ltd. LLZ Class II 2010-10-15
K102024 RPM RESPIRATORY GATING SYSTEM Varian Medical Systems IYE Class II 2010-10-15
K102041 AIXPLORER Supersonic Imagine ITX Class II 2010-10-13
K101149 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Ge Vingmed Ultrasound AS IYO Class II 2010-10-13
K102671 SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 Siemens Medical Solutions USA, Inc. IYE Class II 2010-10-12
K102000 IMAGYS Keosys Sas LLZ Class II 2010-10-12
K102529 D2RF DIGITAL DYNAMIC REMOTE SYSTEM Stephanix Radiological Systems OWB Class II 2010-10-07
K102476 TELERADPRO Vidar Systems Corp. LMA Class II 2010-10-07
K102604 I-LOGIC INREACH SYSTEM Superdimension, Ltd. JAK Class II 2010-10-07
K101166 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ GE Healthcare LLZ Class II 2010-10-07
K102556 VOLPARA, VERSION 1.3 Matakina Technology Limited LLZ Class II 2010-10-07
K101768 MIE SCINTRON GAMMA CAMERA SYSTEMS Miegmbh KPS Class II 2010-10-05
K101324 GE ECHOPAC MODEL BT10 Ge Vingmed Ultrasound AS LLZ Class II 2010-10-05
K102256 GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND Ge Medical Systems China Co., Ltd. IYN Class II 2010-10-05
K102150 SYNGO DYNAMICS, VERSION 9.0 Siemens Medical Solutions USA, Inc. LLZ Class II 2010-10-05
K101813 IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO Imris, Inc. LNH Class II 2010-10-05
K093816 DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 Medien International Co, Ltd. KPR Class II 2010-10-05
K101874 GE LOGIQ P6/P6 PRO GE Healthcare IYN Class II 2010-10-05
K102687 MIRADA RT Mirada Medical, Ltd. LLZ Class II 2010-10-04
K102104 GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Wipro GE Healthcare Private, Ltd. IYN Class II 2010-10-01
K102684 XELIS DENTAL Infinitt Co., Ltd. LLZ Class II 2010-10-01
K101992 3D SCANNER, MODEL 1230 Sun Nuclear Corp. IYE Class II 2010-10-01
K102216 XIO RTP SYSTEM Computerized Medical Systems, Inc. MUJ Class II 2010-10-01
K101347 MAGNETOM AERA; MAGNETOM SKYRA Siemens Medical Solutions USA, Inc. LNH Class II 2010-10-01
K101311 EP NAVIGATOR R3 Philips Medical Systems North America Co. LLZ Class II 2010-09-30
K101337 A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM Sonoscape Company Limited IYO Class II 2010-09-30
K102373 CALYPSO SYSTEM WITH DYNAMIC EDGE GATING Calypso Medical Technologies, Inc. LHN Class II 2010-09-30
K101697 ENSITE VERISMO SEGMENTATION TOOL V.2.0 St Jude Medical LLZ Class II 2010-09-22
K100793 UROSTATION 3D PROSTATE SUITE Koelis LLZ Class II 2010-09-22
K102017 SC2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2010-09-20
K101039 SHIMADZU COLLIMATOR R-300 Shimadzu Corp. IZW Class II 2010-09-20
K101429 ECO SUPERGEL Ceracarta Spa IYO Class II 2010-09-15
K101373 EMBRACE Izi Medical Products, Inc. IZH Class II 2010-09-15
K101435 IMIX PANORAD AND SOMARAD Imix Adr Finland OY KPR Class II 2010-09-15
K101868 INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Toshiba America Medical Systems, In.C OWB Class II 2010-09-07
K102011 ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc. MUJ Class II 2010-09-03
K101550 BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc. KPS Class II 2010-09-03
K101605 MYLABONE ULTRASOUND SYSTEM Esaote Europe B.V. IYN Class II 2010-08-31
K101878 GE LOGIQ P5 MODEL H44662LD GE Healthcare IYN Class II 2010-08-31
K102155 MR RADIATION ONCOLOGY OPTIONS Ge Medical Systems, LLC LNH Class II 2010-08-31
K100102 CS-SERIES-FP Omega Medical Imaging, Inc. OWB Class II 2010-08-31
K093689 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS Mr Medical Solutions, LLC MOS Class II 2010-08-31
K100141 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. MOS Class II 2010-08-27
K101036 SHIMADZU COLLIMATOR R-20J Shimadzu Corp. IZX Class II 2010-08-26
K101632 METAFLEXCOIL Neocoil, LLC MOS Class II 2010-08-24
K093269 PROCEDURE REHEARSAL STUDIO Simbionix , Ltd. LLZ Class II 2010-08-20
K101342 OSIRIX MD Pixmeo Sarl LLZ Class II 2010-08-20
K101816 STN PROBE Summit Doppler Systems, Inc. ITX Class II 2010-08-19
K091047 NEONATE ARRAY COILS Lmt Medical Systems GmbH MOS Class II 2010-08-18
K102148 CURIEPACS (DICOM PACS SOFTWARE) Moksha Digital Software Pvt Limited LLZ Class II 2010-08-17
K101038 RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER Acceletronics Digital Imaging, LLC KPQ Class II 2010-08-17
K102012 DIGITAL RADIOGRAPHY Canon Inc. -Medical Equipment Group MQB Class II 2010-08-17
K101749 SYNGO TRUED SOFTWARE Siemens Medical Solutions LLZ Class II 2010-08-16
K090947 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) Totoku Electric Co., Ltd. LLZ Class II 2010-08-16
K101757 SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc. ITX Class II 2010-08-12
K102113 GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND Ge Medical Systems China Co., Ltd. IYN Class II 2010-08-12
K101666 SYNGO. PLAZA VA20A Siemens AG Medical Solutions LLZ Class II 2010-08-10
K101751 VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR Varian Medical Systems, Oncology Systems IYE Class II 2010-08-10
K091090 DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 E-Woo Technology MQB Class II 2010-08-09
K102005 ALLURA XPER OR TABLE SERIES Philips Medical Systems North America, Inc. OWB Class II 2010-08-09
K101452 CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW Capintec, Inc. KPT Class II 2010-08-09
K101508 MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A. LHN Class II 2010-08-06
K102065 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM Medison Co., Ltd. IYN Class II 2010-08-06
K091529 ICAD VERALOOK CTC CAD SOFTWARE Icad, Inc. JAK Class II 2010-08-04

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