meddevicedb.com FDA Device Reference

Review Panel

Radiology FDA 510(k) Clearances & Devices

Cleared Devices
14,721
Product Codes (page)
25
Latest Decision
2013-06-25

Clearances · page 55 of 148

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K131489 TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION Tractus Corporation IYO Class II 2013-06-25
K131314 DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM) Swissray Medical AG MQB Class II 2013-06-25
K130833 DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2013-06-21
K131213 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2013-06-21
K123106 DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A Samsung Electronics Co., Ltd. KPR Class II 2013-06-20
K131267 VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 GE Healthcare IYN Class II 2013-06-19
K130695 Z5 DIAGNOSTIC ULTRASOUND SYSTEM Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN Class II 2013-06-19
K130499 IU22 DIAGNOSTIC ULTRASOUND SYSTEM Philips Ultrasound, Inc. IYN Class II 2013-06-18
K130801 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2013-06-14
K130542 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS Fujifilm Medical System U.S.A., Inc. LLZ Class II 2013-06-14
K121284 CHABNER XRT GARMENTS Chabner Xrt, LLC IYE Class II 2013-06-14
K130902 EMORY CARDIAC TOOLBOX 3.2 Syntermed, Inc. KPS Class II 2013-06-14
K130992 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM Philips Medical Systems (Cleveland), Inc. IYE Class II 2013-06-14
K130443 I-MAX TOUCH 3D Owandy OAS Class II 2013-06-14
K130567 DR LONG LENGTH IMAGING SOFTWARE Carestream Health, Inc. MQB Class II 2013-06-11
K123520 MAMMOMAT INSPIRATION PRIME Siemens Medical Solutions USA, Inc. MUE Class II 2013-06-11
K131528 NON-PYROGENIC ULTRASOUND TRANSDUCER COVER CIVCO Medical Instruments Co., Inc. ITX Class II 2013-06-11
K123576 IMR SOFTWARE APPLICATION Philips Healthcare (Cleveland) JAK Class II 2013-06-07
K130464 CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR Carestream Health, Inc. MQB Class II 2013-06-07
K123105 XGEO GU60 Samsung Electronics Co., Ltd. KPR Class II 2013-06-07
K130944 ISR'OBOT MONA LISA Biobot Surgical Pte., Ltd. IYO Class II 2013-06-07
K130636 TELERADPRO EDGE; TELERADPRO EDGE HD-CCD Vidar Systems Corp. LMA Class II 2013-06-07
K130645 AQUILION PRIME, V5.00 Toshibamedical Systems Corporation JAK Class II 2013-06-06
K130739 ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS Siemens Medical Solutions USA, Inc. IYN Class II 2013-06-06
K130277 SINGLE ENERGY (SE) FEMUR EXAMS Hologic, Inc. KGI Class II 2013-05-31
K130432 PHT-6500, PHT-60CFO VATECH Co., Ltd. OAS Class II 2013-05-31
K130297 SCANORA 3DX Palodex Group OY OAS Class II 2013-05-29
K130278 MR PERMEABILITY Philips Medical Systems Nederland B.V. LLZ Class II 2013-05-29
K131295 NIO COLOR 3MP LED Barco N.V. LLZ Class II 2013-05-29
K131392 ETIAM PACS COMPONENTS Etiam S.A.S.U. LLZ Class II 2013-05-29
K131088 PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2013-05-24
K131209 TERASON USMART3200T ULTRASOUND SYSTEM Teratech Corp. IYN Class II 2013-05-24
K131246 CORONIS 3MP Barco N.V. LLZ Class II 2013-05-24
K130115 DISCOVERY MR750W 3.0T Ge Medical Systems, LLC LNH Class II 2013-05-23
K131299 ANYTHINK PACS WORKSTATION Beijing Crealife Technology Co., Ltd. LLZ Class II 2013-05-22
K130842 ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES Philips Medical Systems Nederland B.V. IZI Class II 2013-05-21
K123306 NORDIC TUMOREX Nordicneurolab LLZ Class II 2013-05-20
K130457 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL Resonance Innovations, LLC MOS Class II 2013-05-20
K123510 MAGNETOM SKYRA Siemens Medical Solutions USA, Inc. LNH Class II 2013-05-17
K130885 MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT Siemens Medical Solutions USA, Inc. LNH Class II 2013-05-17
K130451 NEUROQ 3.6 Syntermed, Inc. KPS Class II 2013-05-17
K130377 KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM Medicatech USA MQB Class II 2013-05-17
K123603 OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME Ge Healthcare Surgery GE Oec Medical Systems, Inc. OXO Class II 2013-05-17
K124051 THE VAULT SYSTEM Somersault Orthopedics, Inc. LLZ Class II 2013-05-17
K123082 MOBILECT VIEWER Nephosity, Inc. LLZ Class II 2013-05-16
K122644 ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 Siemens Medical Solutions USA, Inc. OWB Class II 2013-05-16
K131118 4D VIEW GE Healthcare LLZ Class II 2013-05-16
K123985 SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 Sensus Healthcare JAD Class II 2013-05-14
K123912 KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET Spencer Fillmore JAQ Class II 2013-05-14
K130159 QLAB QUANTIFICATION SOFTWARE HEART MODEL Philips Health Care LLZ Class II 2013-05-13
K123381 HYPERION X9 Cefla S.C. OAS Class II 2013-05-10
K130617 RAYSTATION Raysearch Laboratories AB MUJ Class II 2013-05-10
DEN120022 X-RAY ATTENUATING CREAM Bloxr Corporation PDK Class II 2013-05-09
K130624 CONI Globalmed LLZ Class II 2013-05-07
K121243 ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER MEDA Co., Ltd. IYO Class II 2013-05-03
K123500 AQUILION LB TRITON V4.91 Toshibamedical Systems Corporation JAK Class II 2013-05-02
K123941 KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI CYLINDER SET Spencer Fillmore JAQ Class II 2013-04-30
K122888 CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM Cdr Systems, Inc. IYE Class II 2013-04-30
K130406 DIAGNOSTICPRO EDGE Vidar Systems Corp. LMA Class II 2013-04-29
K122510 ICRCO 3600M Icrco, Inc. MUE Class II 2013-04-26
K120800 NVISION VLE IMAGING SYSTEM Ninepoint Medical, Inc. NQQ Class II 2013-04-25
K130318 NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) Varian Medical Systems, X-Ray Products-Infimed JAA Class II 2013-04-22
K130269 ECAT SCINTRON PET Miegmbh KPS Class II 2013-04-19
K130883 SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T Sedecal., Sa. MQB Class II 2013-04-18
K130770 MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR Nec Display Solutions , Ltd. LLZ Class II 2013-04-18
K130772 MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR Nec Display Solutions , Ltd. LLZ Class II 2013-04-18
K122199 PREXION3D ECLIPSE The Yoshida Dental Mfg. Co., Ltd. OAS Class II 2013-04-18
K130929 ZMED VP4000 Zmed, Inc. LLZ Class II 2013-04-12
K130678 BIOMARC GOLD FIDUCIAL MARKER Carbon Medical Technologies, Inc. IYE Class II 2013-04-12
K130119 PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM Sonoscape Company Limited IYN Class II 2013-04-12
K122537 PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical IYN Class II 2013-04-12
K130803 UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM Samsung Medison Co., Ltd. IYN Class II 2013-04-12
K130884 XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION Ge Medical Systems F.I. Haifa LLZ Class II 2013-04-12
K123708 SPINE COIL Usa Paramed Medical Systems, Inc. MOS Class II 2013-04-10
K130383 SYNAPSE 3D CARDIAC TOOLS Fujifilm Medical System U.S.A., Inc. LLZ Class II 2013-04-09
K130069 INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 GE Healthcare LLZ Class II 2013-04-05
K130308 NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM Hitachi Aloka Medical, Ltd. IYN Class II 2013-04-05
K123806 FIBROSCAN Echosens IYO Class II 2013-04-05
K123808 AGILITY Elekta , Ltd. IYE Class II 2013-04-04
K123263 HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS Eckert & Ziegler Bebig GmbH MUJ Class II 2013-04-04
K130659 SPEQRT ULTRASOUND SYSTEM Signostics Pty, Ltd. IYN Class II 2013-04-03
K130453 EXCELSIOR Eyekor, LLC NFJ Class II 2013-04-02
K121916 INTUITION Terarecon,Inc. LLZ Class II 2013-04-02
K123541 SYNGO.CT NEURO PERFUSION Siemens Medical Systems, Inc. JAK Class II 2013-04-02
K123509 SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. JAK Class II 2013-03-29
K123272 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM Neocoil, LLC MOS Class II 2013-03-28
K130336 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 Eizo Nanao Corporation LLZ Class II 2013-03-28
K123976 NOBELCLINICIAN Nobel Biocare AB LLZ Class II 2013-03-26
K130754 ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medi Cal Solutions, Inc. IYN Class II 2013-03-25
K130173 SONOSITE MAXX SERIES ULTRASOUND SYSTEM FUJIFILM Sonosite, Inc. IYN Class II 2013-03-25
K130619 ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc. IYN Class II 2013-03-21
K121772 ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 Philips Medical Systems Nederland B.V. OWB Class II 2013-03-21
K130393 MIRADA RTX Mirada Medical, Ltd. LLZ Class II 2013-03-20
K130229 PALM BLADDER SCANNER Mianyang Meike Electronic Equipment Co., Ltd. IYO Class II 2013-03-20
K130228 SUITEHEART Neosoft, LLC LLZ Class II 2013-03-20
K123070 GALILEOS FAMILY Sirona Dental Systems GmbH OAS Class II 2013-03-15
K123186 RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 Calgary Scientific, Inc. LLZ Class II 2013-03-14
K130251 ESOPHAGUS BOUGIE SET Varian Medical Systems, Inc. JAQ Class II 2013-03-13
K123522 OPTIMA MR450W Ge Healthcare (Ge Medical Systems, LLC) LNH Class II 2013-03-13
K123584 SYNGO, CT BONE READING Siemens Medical Solutions USA, Inc. JAK Class II 2013-03-12

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