meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
29
Latest Decision
2013-03-12

Clearances · page 56 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K122981 RAYSCAN A-EXPERT 3D Ray Co., Ltd. OAS Class II 2013-03-12
K123345 DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA Rayence Co., Ltd. MQB Class II 2013-03-12
K123815 SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE Varian Medical Systems, Inc. JAQ Class II 2013-03-11
K122736 DX-D IMAGING PACKAGE Agfa Healthcare N.V. MQB Class II 2013-03-11
K130395 STEREOS WORKSTATION Eos Imaging, Inc. LLZ Class II 2013-03-11
K123464 CALLISTO EYE Carl Zeiss Meditec, AG NFJ Class II 2013-03-05
K123893 CURA COLLIMATOR Cura Medical Technologies, LLC IXI Class II 2013-03-04
K123426 MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS Orpheus Medical , Ltd. LLZ Class II 2013-03-01
K130262 MAGNETOM ESSENZA WITH SYNGO MR D14 Siemens Medical Solutions USA, Inc. LNH Class II 2013-03-01
K130243 ILAB ULTRASOUND IMAGING SYSTEM Boston Scientific Corp IYO Class II 2013-03-01
K123812 COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV Siemens Medical Solutions USA, Inc. IYE Class II 2013-03-01
K123442 XOFT AXXENT CERVICAL APPLICATORS Icad, Inc. JAQ Class II 2013-02-27
K123433 CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE Cedars-Sinai Medical Center KPS Class II 2013-02-26
K123529 ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc. OWB Class II 2013-02-26
K122578 VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING Vital Images, Inc. LLZ Class II 2013-02-25
K123238 ACHILLES Ge Medical Systems China Co., Ltd. MUA Class II 2013-02-25
K130058 ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 Olympus Medical Systems Corp. IYN Class II 2013-02-22
K122286 MAMMOMAL INSPIRATION Siemens Medical Solutions USA, Inc. MUE Class II 2013-02-22
K123646 EMORY CARDIAC TOOLBOX 4.0 Syntermed, Inc. KPS Class II 2013-02-22
K123740 EOS Eos Imaging MQB Class II 2013-02-22
K123681 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL Wipro GE Healthcare Private, Ltd. MOS Class II 2013-02-22
K124002 VERIFICATION CONSOLE Varian Medical Systems LHN Class II 2013-02-21
K123424 MDU5 PLUS STERILE BAG Boston Scientific Corp ITX Class II 2013-02-20
K123650 ARIX RAD ACQUISITION CONSOLE Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. LLZ Class II 2013-02-20
K123575 MAMMOWORKSTATION Image Diagnost International GmbH LLZ Class II 2013-02-19
K120851 COMMUNIFY PACS VIEWER Communify Health, LLC LLZ Class II 2013-02-19
K122726 CPI RAD VISION Communications & Power Industries Canada, Inc. KPR Class II 2013-02-15
K122710 TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND Shenzhen Delicate Electronics Co., Ltd. IYN Class II 2013-02-15
K123254 ULTRASOUND SCANNER FLEX FOCUS B-K Medical Aps IYN Class II 2013-02-13
K123097 DOSE TRACKING SYSTEM MODEL XIDF-DTS801 Toshiba America Medical Systems, In.C JAA Class II 2013-02-13
K123938 SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN Siemens Medical Solutions USA, Inc. LNH Class II 2013-02-12
K123023 SURGERY REHEARSAL PLATFORM Surgical Theater, LLC LLZ Class II 2013-02-08
K130103 CORONIS FUSION 6MP Barco N.V. LLZ Class II 2013-02-08
K130070 4MP COLOR LCD MONITOR, RADIFORCE RX440 Eizo Nanao Corporation LLZ Class II 2013-02-08
K123596 OPTIMA CT520 Ge Hangwei Medical Systems Co., Ltd. JAK Class II 2013-02-08
K123249 DIAGNOSTIC ULTRASOUND SYSTEM Edan Instruments, Inc. IYN Class II 2013-02-08
K120701 M2 WRIST MRI SYSTEM Aspect Imaging, Ltd. LNH Class II 2013-02-07
K123970 CAAS INTRAVASCULAR Pie Medical Imaging BV LLZ Class II 2013-02-06
K123992 APLIO 500/400/300 V3.0 Toshibamedical Systems Corporation IYN Class II 2013-02-06
K130041 SHEATHES STERILE ULTRASOUND GEL Sheathing Technologies, Inc. MUI Class II 2013-02-06
K123519 INVIVO DENTAL Anatomage, Inc. LLZ Class II 2013-02-01
K122865 VIVIX-S WIRELESS Vieworks Co., Ltd. MQB Class II 2013-02-01
K121418 PLANMED VERITY Planmed OY JAK Class II 2013-02-01
K123995 MICRODOSE SI Philips Digital Mammography Sweden AB MUE Class II 2013-02-01
K123420 SYNGO, BREAST CARE Siemens Medical Solutions USA, Inc. LLZ Class II 2013-02-01
K123610 E-CUBE 15 Alpinion Medical Systems Co., Ltd. IYN Class II 2013-02-01
K122928 DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA Rayence Co., Ltd. MQB Class II 2013-01-30
K123369 ILUMIEN OPTIS Lightlab Imaging, Inc. NQQ Class II 2013-01-30
K123894 GE ECHOPAC Ge Vingmed Ultrasound AS LLZ Class II 2013-01-29
K123349 A-SCAN PLUS CONNECT Accutome, Inc. IYO Class II 2013-01-29
K123737 BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc. KPS Class II 2013-01-29
K124048 IMAGEQUBE Intuitive Imaging Informatics, LLC LLZ Class II 2013-01-29
K123269 PROCEDURE REHEARSAL STUDIO Simbionix , Ltd. LLZ Class II 2013-01-29
K123873 CONTRAST ENHANCED DIGITAL MAMMOGRAPHY Hologic, Inc. MUE Class II 2013-01-29
K123901 TRACTUS TISSUEMAPPER REVIEWER APPLICATION Tractus Corporation LLZ Class II 2013-01-29
K123917 DECLIPSESPECT VIEWER Surgiceye GmbH IZD Class I 2013-01-25
DEN130012 FERRISCAN R2-MRI ANALYSIS SYSTEM Resonance Health Analysis Services Pty, Ltd. PCS Class II 2013-01-23
K123566 SYNAPSE 3D COLON ANALYSIS Fujifilm Medical Systems U.S.A, Inc. LLZ Class II 2013-01-22
K123577 SYNGO.VIA MI WORKFLOWS Siemens Medical Solutions USA, Inc. LLZ Class II 2013-01-22
K123098 XGEO GC80 Samsung Electronics Co., Ltd. KPR Class II 2013-01-18
K123920 SYNGO.VIA Siemens AG Medical Solutions LLZ Class II 2013-01-18
K123828 PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM Hitachi Aloka Medical, Ltd. IYN Class II 2013-01-18
K122768 GENESIS Dornier Medtech America, Inc. JAA Class II 2013-01-18
K121762 CARDIAC VX Ge Medical Systems, LLC LLZ Class II 2013-01-18
K122951 XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 Icad, Inc. JAD Class II 2013-01-17
K123417 BRIVO MR355, OPTIMA MR360 Ge Hangwei Medical Systems Co., Ltd. LNH Class II 2013-01-17
K123922 SYNGO DYNAMICS Siemens Medical Solutions USA, Inc. LLZ Class II 2013-01-16
K123788 INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) Varian Medical Systems, Inc. IYE Class II 2013-01-15
K123408 ERGO IMAGING SYSTEM Digirad Corp. IYX Class I 2013-01-15
K123535 ILAB ULTRASOUND IMAGING SYSTEM Boston Scientific Corp IYO Class II 2013-01-15
K123898 VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM Volcano Corporation IYO Class II 2013-01-14
K123414 SPECBOARD JR. Macbrud Corp., Medical Division IZH Class II 2013-01-11
K123327 1.5T GEM RT OPEN ARRAY Ge Healthcare Coils (Usa Instruments, Inc.) MOS Class II 2013-01-11
K123644 VIZION + DR Viztek, LLC MQB Class II 2013-01-11
K122836 AFFIRM BREAST BIOPSY GUIDANCE SYSTEM Lorad, A Hologic Co. IZH Class II 2013-01-11
K122866 VIVIX-S WITH VXVUE Vieworks Co., Ltd. MQB Class II 2013-01-11
K123302 IB CLINIC Imaging Biometrics, LLC LLZ Class II 2013-01-11
K122704 BEST LOCALIZATION NEEDLE WITH I-125 SEED Best Medical Intl. KXK Class II 2013-01-09
K123371 ALIGNRT PLUS Vision RT Limited IYE Class II 2013-01-08
K121296 INTERVENTIONAL WORKSPOT Philips Medical Systems Nederland B.V. LLZ Class II 2013-01-02
K122457 GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE Healthcare OWB Class II 2013-01-02
K122919 DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA Rayence Co., Ltd. MQB Class II 2013-01-01
K122764 RAPID STRAND RX Medi-Physics, Inc. KXK Class II 2012-12-28
K123357 ONQ RTS Oncology Systems, Inc. MUJ Class II 2012-12-28
K123526 CLEARREAD +CONFIRM Riverain Technologies LLZ Class II 2012-12-27
K123091 VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T Imris, Inc. MOS Class II 2012-12-27
K121653 INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS Carl Zeiss Meditec, Inc. JAD Class II 2012-12-27
K122909 SYNGO SINGLE SOURCE DUAL ENGERY Siemens Medical Systems, Inc. JAK Class II 2012-12-27
K123754 CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2012-12-21
K122897 SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 Invivo Corporation MOS Class II 2012-12-21
K123611 E-CUBE 7 Alpinion Medical Systems Co., Ltd. IYN Class II 2012-12-21
K120948 PREXION 3D The Yoshida Dental Mfg. Co., Ltd. OAS Class II 2012-12-21
K123616 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM Sonoscape Company Limited IYO Class II 2012-12-21
K122616 PANTHER OIS/R & V MODEL VERSION 2.0 Prowess, Inc. IYE Class II 2012-12-21
K122106 SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE Veran Medical Technologies, Inc. JAK Class II 2012-12-21
K123530 MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) Hologic, Inc. LLZ Class II 2012-12-20
K123528 SCENIUM Siemens Medical Solutions USA, Inc. LLZ Class II 2012-12-20
K123499 AEROPILOT Konica Minolta Medical & Graphic, Inc. MQB Class II 2012-12-20
K123585 SYNGO, CT CARDIAC FUNCTION Siemens Medical Solutions USA, Inc. JAK Class II 2012-12-20
K123291 TRUEBEAM Varian Medical Systems, Inc. IYE Class II 2012-12-20

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