meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
23
Latest Decision
2014-01-31

Clearances · page 53 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133034 LOGIQ F SERIES GE Healthcare IYN Class II 2014-01-31
K133240 VARIAN MULTILEAF COLLIMATOR Varian Medical Systems, Inc. IYE Class II 2014-01-31
K134002 6MP COLOR LCD MONITOR, RADIFORCE RX650 Eizo Corporation LLZ Class II 2014-01-31
K130003 XIRALITE FLOURESCENCE IMAGING SYSTEM X4 Mivenion GmbH IZI Class II 2014-01-31
K132770 DOME S10 Nds Surgical Imaging LLZ Class II 2014-01-30
DEN130036 PROSTATE IMMOBILIZER RECTAL BALLOON Radiadyne PCT Class II 2014-01-28
K132444 ATAMA SYSTEM Monteris Medical, MOS Class II 2014-01-27
K133986 1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY Resonance Innovations, LLC MOS Class II 2014-01-27
K133331 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems, Inc. MUJ Class II 2014-01-27
K133259 YSIO MAX Siemens Medical Solutions USA, Inc. KPR Class II 2014-01-24
K133030 DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) Invivo Corporation LLZ Class II 2014-01-22
K132499 ICRCO CLARITY VIEWER Icrco, Inc. LLZ Class II 2014-01-21
K132410 DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W Ge Medical Systems, LLC JAK Class II 2014-01-17
K133424 SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 Siemens Medical Solutions USA, Inc. JAK Class II 2014-01-17
K132921 GALAXY PLUS Medien International Co, Ltd. MQB Class II 2014-01-17
K133833 NUVIS DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2014-01-17
K133277 XARIO 100 Toshibamedical Systems Corporation IYN Class II 2014-01-17
K133875 THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA Ortho Kinematics, Inc. LLZ Class II 2014-01-17
K133120 COMPUTED RADIOGRAPHY SCANNER 3Disc Americas MQB Class II 2014-01-15
K133106 COMPUTED RADIOGRAPHY SCANNER 3Disc Americas MQB Class II 2014-01-15
K130692 M2 WRIST 2 MRI SYSTEM Aspect Imaging, Ltd. LNH Class II 2014-01-14
K130552 CT PULMONARY ANALYSIS Qi Imaging, LLC JAK Class II 2014-01-13
K133684 ULTRABLOX Bloxr Corporation PDK Class II 2014-01-13
K133191 PROBEAM PROTON THERAPY SYSTEM Varian Medical Systems LHN Class II 2014-01-10
K132346 ULTRASOUND SCANNER PRO FOCUS 2202 B-K Medical Aps IYO Class II 2014-01-10
K132335 ULTRASOUND SCANNER FLEX FOCUS 1202 B-K Medical Aps IYN Class II 2014-01-10
K132677 ULTRASOUND SCANNER FLEX FOCUS 1202 B-K Medical Aps IYN Class II 2014-01-07
K132685 ULTRASOUND SCANNER PRO FOCUS 2202 B-K Medical Aps IYN Class II 2014-01-06
K133686 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) Jvckenwood Corporation LLZ Class II 2014-01-06
K130998 SYNGO.VIA WEB VIEWER Siemens AG Medical Solutions LLZ Class II 2014-01-03
K132969 SPEC MODEL M15 Source Production & Equipment Co., Inc. KXK Class II 2014-01-02
K130901 SOMATOM DEFINITION AS OPEN Siemens Medical Systems, Inc. JAK Class II 2014-01-02
K133490 G-SCAN BRIO Esaote, S.p.A. LNH Class II 2013-12-30
K133505 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2013-12-27
K133422 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE Neocoil, LLC MOS Class II 2013-12-26
K132095 OLEA SPHERE Olea Medical LLZ Class II 2013-12-26
K131164 ACUSON Siemens Medical Solutions USA, Inc. IYN Class II 2013-12-24
K133431 VENUE 50 GE Healthcare IYN Class II 2013-12-24
K131447 INTUITION - TDA, TVA, PARAMETRIC MAPPING Terarecon,Inc. LLZ Class II 2013-12-24
K133367 ORTHOVIS PREOPERATIVE PLAN Custom Orthopaedic Solutions LLZ Class II 2013-12-20
K133641 CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE Volcano Corporation IYO Class II 2013-12-20
K132342 XVWEB Apteryx, Inc. LLZ Class II 2013-12-20
K123209 SOFTVUE Delphinus Medical Technologies, Inc. IYO Class II 2013-12-19
K133511 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) Jvckenwood Corporation LLZ Class II 2013-12-19
K132996 CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS Isoray, Inc. KXK Class II 2013-12-17
K133454 SONOSITE EDGE ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. IYN Class II 2013-12-16
K132963 FUSIONSYNC, CHIMAERA FUSIONSYNC Chimaera GmbH LLZ Class II 2013-12-16
K132147 2D PERFUSION Philips Medical Systems Nederland B.V. OWB Class II 2013-12-16
K122035 HEPAFAT SCAN Resonance Health Analysis Services Pty, Ltd. LNH Class II 2013-12-13
K130704 MICRODOSE SI Philips Digital Mammography Sweden AB MUE Class II 2013-12-13
K131996 S-SCAN Esaote, S.p.A. LNH Class II 2013-12-13
K132523 MYOPERFUSION Toshibamedical Systems Corporation JAK Class II 2013-12-12
K132558 SYNC-RX SYSTEM Volcano Corporation OWB Class II 2013-12-12
K131766 PLATINUM DRF IMAGING SYSTEM Apelem-Dms Group JAA Class II 2013-12-12
K133435 MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A Siemens Medical Solutions USA, Inc. LNH Class II 2013-12-12
K132773 SIDEXIS 4 Sirona Dental Systems GmbH LLZ Class II 2013-12-11
K132532 SYNGO.PLAZA VB10A Siemens AG Healthcare LLZ Class II 2013-12-09
K132904 ZIEHM VISION RFD Ziehm Imaging GmbH JAA Class II 2013-12-05
K132466 MYLABSEVEN 6400, MYLABALPHA 7400 Esaote, S.p.A. IYN Class II 2013-12-04
K133185 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) Jvckenwood Corporation LLZ Class II 2013-12-03
K132742 M-VU BREAST DENSITY Vucomp, Inc. LLZ Class II 2013-12-03
K133181 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) Jvckenwood Corporation LLZ Class II 2013-12-03
K132970 LESSRAY Saferay Spine, LLC OWB Class II 2013-11-29
K132231 MYLABSEVEN, MYLABALPHA Esaote, S.p.A. IYN Class II 2013-11-27
K133329 UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2013-11-27
K132687 E-CUBE 7 Alpinion Medical Systems Co., Ltd. IYN Class II 2013-11-27
K131390 JUSHA-M52C MEDICAL DISPLAY Nanjing Jusha Display Technology Co., Ltd. LLZ Class II 2013-11-27
K132544 TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA Tomtec Imaging Systems GmbH LLZ Class II 2013-11-25
K133357 CHARRUAPACS SYSTEM Charruasoft SA LLZ Class II 2013-11-25
K132509 FDR D-EVO FLAT PANEL DETECTOR SYSTEM Fujifilm Medical Systems U.S.A, Inc. MQB Class II 2013-11-25
K132119 MAGNETOM PRISMA, MAGNETOM PRISMA FIT Siemens Medical Solutions USA, Inc. LNH Class II 2013-11-22
K131689 MRI MARKER C4 Imaging, LLC KXK Class II 2013-11-20
K132847 I2C Ion Beam Applications S.A. LHN Class II 2013-11-20
K132971 MONACO Impac Medical Systems, Inc. MUJ Class II 2013-11-20
K132347 MULTICAM 3000 ECO Inter Medical Medizintechnik GmbH KPS Class II 2013-11-20
K130426 SUMITOMO PROTON THERAPY SYSTEM Sumitomo Heavy Industries, Ltd. LHN Class II 2013-11-19
K132779 DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2013-11-19
K132261 DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) Ge Medical Systems, LLC IZF Class II 2013-11-18
K132376 DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T Ge Healthcare (Ge Medical Systems, LLC) LNH Class II 2013-11-15
K133142 VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION Volcano Corporation IYO Class II 2013-11-15
K132951 MAGNETOM AERA Siemens Medical Solutions USA, Inc. LNH Class II 2013-11-15
K132527 DIGITAL COLOR DOPPLER ULTASOUND SYSTEM Sonoscape Company Limited IYN Class II 2013-11-14
K132605 DOSIMETRY CHECK VERSION 4 RELEASE 1 Math Resolutions, LLC IYE Class II 2013-11-14
K132106 INFINIX ANGIO WORKSTATION W/DTS SOFTWARE Toshiba America Medical Systems, In.C JAA Class II 2013-11-12
K132294 GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS Radiology Solutions, LLC KPR Class II 2013-11-12
K133226 BIOGRAPH MMR Siemens Medical Solutions USA, Inc. OUO Class II 2013-11-12
K132913 VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 GE Healthcare IYN Class II 2013-11-08
K132222 AQUILION ONE VISION, V6.0 Toshibamedical Systems Corporation JAK Class II 2013-11-07
K131423 G-ARM MULTISCAN SYSTEM Beijing East Whale Imaging Technology Co., Ltd. OXO Class II 2013-11-07
K132799 CLARISO PACS Clariso, Inc. LLZ Class II 2013-11-07
K131211 DICOMPACS DX-R WITH FLAT PANEL Oehm Und Rehbein GmbH MQB Class II 2013-11-05
K133134 X-PORTE ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. IYN Class II 2013-11-04
K132124 KLARITY VACUUM BAG, KLARITY MOLD CUSHION Klarity Medical Products, LLC IYE Class II 2013-11-01
K132831 QUIET/SILENT SCANNING SUITE Siemens Medical Solutions USA, Inc. LNH Class II 2013-11-01
K131695 RAYSCAN A-EXPERT 3D Ray Co., Ltd. OAS Class II 2013-11-01
K132705 UNIQUE Varian Medical Systems, Inc. IYE Class II 2013-10-31
K132586 PAXERAPACS Paxeramed LLZ Class II 2013-10-31
K132305 STENTBOOST REL. 4 Philips Medical Systems Nederland B.V. OWB Class II 2013-10-30
K132316 MULTIVIEW Hologic, Inc. LLZ Class II 2013-10-30
K132059 DIAGNOSTIC ULTRASOUND SYSTEM Advanced Instrumentations, Inc. IYN Class II 2013-10-25

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