Atlas FDA

Radiology

14,649 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
Vitrea CT Lung Density Analysis Software (K151919)Vital Images, Inc.2015-10-10
D2RS_AT Digital Dynamic Remote System (K150306)Stephanix Radiological Solutions2015-10-10
SOMATOM Definition Edge, SOMATOM Definition AS/AS+ (K152036)Siemens Medical Solutions USA, Inc.2015-10-09
Aquilion Lightning (TSX-035A/2, V7.0) (K151833)Toshibamedical Systems Corporation2015-10-09
ULTRASOUND SYSTEM SONIMAGE HS 1 (K152577)Konica Minolta, Inc.2015-10-08
DEXIS Webview (K151941)Imaging Sciences International /Gendex/Dexis2015-10-07
ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System (K152369)Siemens Medical Solutions USA, Inc. Ultrasound Group2015-10-06
Ultrasound Scanner System BK2300 (K151910)Bk Medical Aps2015-10-05
ADX6000 Portable X-Ray System; iRayA6 (K143494)Dexcowin Co., Ltd.2015-10-05
CygneX I System (K143560)Accuthera, Inc.2015-10-05
Extended Range Shifter for PROBEAT-V (K152207)Hitachi, Ltd., Health Care Company2015-10-02
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems (K152545)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-10-02
OrthoVis Web Portal (K151501)Custom Orthopaedic Solutions, Inc.2015-10-02
Synergy ODM (K151952)Topcon Medical Systems, Inc.2015-10-01
Supria Whole-body X-ray CT System (K150565)Hitachi Medical Systems America, Inc.2015-09-30
MultiScan G-Arm System (K151280)Beijing East Whale Imaging Technology Co., Ltd.2015-09-30
LOGIQ S8 (K152195)GE Healthcare2015-09-29
MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit (K151579)Siemens Medical Solutions USA, Inc.2015-09-29
Onrad Treatment System (K152488)Accuray Incorporated2015-09-28
Permanent Sled Bag (K152403)Boston Scientific2015-09-22
ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System (K152469)Siemens Medical Solutions, Inc., Ultrasound Division2015-09-21
CARESTREAM Vue Motion (K151774)Carestream Health, Inc.2015-09-21
Eclipse Treatment Planning System (K152393)Varian Medical Systems, Inc.2015-09-18
iLab Ultrasound Imaging System (K152316)Boston Scientific2015-09-18
Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (K152030)Qingdao Hisense Medical Equipment Co., Ltd.2015-09-16
syngo VSim (K151887)Siemens Medical Solutions USA, Inc.2015-09-16
Radio Therapy Treatment Chair (K150382)Radiation Products Design, Inc.2015-09-16
Ultrasound Scanner System bk2300 (K152052)Bk Medical Aps2015-09-16
MAMMOMAT Fusion (K151645)Siemens Medical Solutions USA, Inc.2015-09-14
LOGIQ E9, LOGIQ E9 XDClear 2.0 (K152309)GE Medical Systems Ultrasound and Primary Care Diagnostics2015-09-14
CT Sim Laser System (K152303)Gammex, Inc.2015-09-11
QuickPlan (K151560)Siris Medical2015-09-11
Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets (K152018)Varian Medical Systems, Inc.2015-09-11
JUSHA-C23C LCD Monitor (K151861)Nanjing Jusha Display Technology Co., Ltd.2015-09-10
SONON Ultrasound Imaging System (Model: SONON 300C) (K151339)Healcerion Co., Ltd.2015-09-10
ViZion DR + Wireless (K152279)Viztek, LLC2015-09-10
JUSHA-C43 LCD Monitor (K151972)Nanjing Jusha Display Technology Co., Ltd.2015-09-10
S-scan (K151668)Esaote, S.p.A.2015-09-08
CAREVIEW 1800R (K141488)Careray Digital Medical System Co., Ltd.2015-09-08
SpeqRT (K152250)Signostics Limited2015-09-03
S12 Digital Color Doppler Ultrasound System (K152396)Sonoscape Medical Corp.2015-09-03
OPUS 5100 Diagnostic Doppler Ultrasound System (K142982)Chang Gung Medical Technology Co., Ltd.2015-09-03
Model 206 Electrometer/Dosimeter (K150265)Cnmc Company Incorporated2015-09-03
Leksell GammaPlan (K151666)Elekta Instrument AB2015-09-03
FACT Medical Imaging Sysytem (K143586)Dexin Medical Imaging Technology Co., Ltd.2015-09-02
BOX DICOM Viewer (K151957)Box, Inc.2015-09-01
FibroScan (K150239)Echosens2015-09-01
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System (K152164)Sonoscape Medical Corp.2015-08-28
16 ch Tx/Rx Knee SPEEDER (K151753)Quality Electrodynamics, LLC2015-08-27
S9 Portable Digital Color Doppler Ultrasound System (K152165)Sonoscape Medical Corp.2015-08-26
HealthMyne PACS (K152186)Healthmyne, Inc.2015-08-20
FUJIFILM SonoSite X-Porte Ultrasound System (K152209)FUJIFILM Sonosite, Inc.2015-08-19
CS 3D Imaging (K151837)Trophy2015-08-19
Corporate Dental Imaging (CDI) Application (K151371)U.S. Army Dental Command (Dencom)2015-08-19
ScandiDos Delta4 Phantom+ (K151180)Scandidos AB2015-08-19
EDOSE (K150767)Guangzhou Raydose Software Technology., LLC2015-08-17
VesselNavigator Rel. 1.0 (K151598)Philips Medical Systems Nederland B.V.2015-08-17
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems (K151372)Ge Medical Systems, LLC2015-08-14
Respiratory Gating for Scanners (K151533)Varian Medical Systems, Inc.2015-08-13
syngo.via RT Image Suite (K151380)Siemens Medical Solutions USA, Inc.2015-08-13
RS80A Diagnostic Ultrasound System (K151663)Samsung Medison Co., Ltd.2015-08-12
Synapse Cardiovascular (K151859)Fujifilm Medical Systems U.S.A, Inc.2015-08-12
McKesson Cardiology (K151850)Mckesson Israel , Ltd.2015-08-11
syngo.CT Single Source Dual Energy (K150745)Siemens Medical Solutions USA, Inc.2015-08-11
syngo.CT Dual Energy (K150757)Siemens Medical Solutions USA, Inc.2015-08-11
Philips Spectral CT Applications (K150665)Philips Medical Systems Nethrlands BV2015-08-07
Q-Rad Radiographic System with Auto-Tracker Option (K151924)Quantum Medical Imaging Divison of Carestream2015-08-07
8ch Foot Ankle Coil (K151653)Shenzhen RF Tech Co., Ltd.2015-08-07
syngo.MR Neurology, syngo.MR Oncology (K151353)Siemens Medical Solutions USA, Inc.2015-08-07
.decimal p.d (K151369).Decimal, LLC2015-08-07
Shielded Applicator Set, Cervical Stop (K151657)Varian Medical Systems, Inc.2015-08-07
O-Arm O2 Imaging System (K151000)Medtronic, Inc.2015-08-06
OPTIS Integrated System Mobile Workstation (K151286)Lightlab Imaging, Inc.2015-08-05
CareView 1500Cw X-ray Flat Panel Detectors (K150929)Careray Digital Medical System Co., Ltd.2015-08-04
Leksell Gamma Knife Icon (K151561)Elekta Instrument AB2015-08-04
Models 2200DR and 1600DR Digital Stationary Radiographic Systems (K151219)Beijing Polycon Medical Engineering Company2015-08-04
QuantorView (K151687)3Disc Americas2015-08-03
SyncVision System (K151904)Volcano Corporation2015-07-31
Arthrex OrthoVis Preoperative Plan (K151568)Custom Orthopaedic Solutions, Inc.2015-07-31
5MP Monochrome LCD Monitor, RadiForce GX540 (K151883)Eizo Corporation2015-07-30
ECHELON Oval V 5.0 MRI System (K151015)Hitachi Medical Systems America, Inc.2015-07-29
3D/5D Viewer (K151808)Samsung Medison Co., Ltd.2015-07-29
Atlas SPEEDER Header/Neck (K151829)Quality Electrodynamics, LLC2015-07-29
GenIQ (K143368)Ge Medical Systems, LLC2015-07-29
3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display (K151854)D-View Display Technology Co., Ltd.2015-07-28
QBit Series Diagnostic Ultrasound System (K150861)Chison Medical Imaging Co., Ltd.2015-07-28
Proton Immobilization Solution (K151207)Orfit Industries NV2015-07-28
EPX-Series Mobile X-ray System (K151038)Ecotron Co., Ltd.2015-07-24
iuStar300 Medical Ultrasound Diagnostic System (K141720)United Imaging Systems (Beijing) Co., Ltd.2015-07-23
E-CUBE 15 Diagnostic Ultrasound System (K150773)Alpinion Medical Systems Co., Ltd.2015-07-23
GUA60A, GU60A-65 (K151685)Samsung Electronics Co., Ltd.2015-07-17
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 (K150839)Varian Medical Systems, Inc.2015-07-17
Hi-Light Diagnostic Ultrasound Systems (K151709)Qingdao Hisense Medical Equipment Co., Ltd.2015-07-17
Coronis Uniti (K151505)Barco N.V.2015-07-17
UltraLinq (K143176)Ultralinq Healthcare Solutions, Inc.2015-07-17
Biograph mCT and mCT Flow PET/CT Scanners (K151486)Siemens Medical Solutions USA, Inc.2015-07-17
ILUMIEN OPTIS (K150878)Lightlab Imaging, Inc.2015-07-15
Aura DR 43C-AG flat panel detector (K151014)Abyzr Co., Ltd.2015-07-13
Vitrea Software Toshiba Package, VSTP-001A (K151091)Toshibamedical Systems Corporation2015-07-13
SIGNA Pioneer (K143345)Ge Healthcare Japan Corporation2015-07-10
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