Atlas FDA

Radiology

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

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RecordFirmDate
TRINITY (K160357)Koelis2016-05-02
MX50T(MX50TQS) (K160354)Wide Corporation2016-05-02
TBS iNsight (K152299)Medimaps Group SA2016-04-29
Mobius3D (K153014)Mobius Medical Systems, LP2016-04-29
Voluson P6, Voluson P8 (K160162)GE Healthcare2016-04-26
MIM-Thin Client (mobile) (K151913)Mim Software, Inc.2016-04-25
sterEOS Workstation (K160914)Eos Imaging, Inc.2016-04-22
MX50N(MX50YQS) (K160353)Wide Corporation2016-04-22
Anzai Respiratory Gating System (K160432)Anzai Medical Co., Ltd.2016-04-22
PROBEAT-V and accessories (K153614)Hitachi, Ltd., Health Care Company2016-04-21
Leksell Gamma Knife Icon (K160440)Elekta Instrument AB2016-04-20
AIRO Computed Tomography (CT) X-ray System (K160126)Mobius Imaging2016-04-19
Fujifilm Sonosite Vevo MD Imaging System (K160674)FUJIFILM Sonosite, Inc.2016-04-19
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit (K153343)Siemens Medi Cal Solutions, Inc.2016-04-15
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound (K160792)The Prometheus Group2016-04-15
CX30N (CX30PQX) (K160348)Wide Corporation2016-04-14
MX30N(MX30TQS) (K160346)Wide Corporation2016-04-14
DICOM Viewer (K153653)Brainlab AG2016-04-13
Varian Sterilization Boxes (K160021)Varian Medical Systems, Inc.2016-04-13
EndoSize (K160376)Therenva Sas2016-04-12
RayStation (K160093)RaySearch Laboratories AB (PUBL)2016-04-08
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software (K160579)Rayence Co., Ltd.2016-04-08
FDR D-EVO flat Panel Detector System (K153464)Fujifilm Medical Systems U.S.A, Inc.2016-04-08
Bladder Scanner (K153581)Caresono Technology Co., Ltd.2016-04-08
Philips Multislice CT System with Low Dose CT Lung Cancer (K153444)Philips Medical Systems (Cleveland), Inc.2016-04-08
spineEOS (K160407)Onefit Medical2016-04-08
CX50N, CX50YQS (K160351)Wide Corporation2016-04-07
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner (K160343)Beijing East Whale Imaging Technology Co., Ltd.2016-04-07
CX20N(CX20PUX) (K160355)Wide Corporation2016-04-07
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (K160807)Philips Ultrasound, Inc.2016-04-06
SonoSite SII Ultrasound System (K160734)FUJIFILM Sonosite, Inc.2016-04-05
Acclarix LX8 Diagnostic Ultrasound System (K160790)Edan Instruments, Inc.2016-04-04
S45 Digital Color Doppler Ultrasound System (K160283)Sonoscape Medical Corp.2016-04-04
X5 Digital Color Doppler Ultrasound System (K160258)Sonoscape Medical Corp.2016-04-01
Aquilion Lightning, TSX-035A/4 and /5, V7.0 (K153263)Toshibamedical Systems Corporation2016-04-01
BioVision Plus (K153583)Faxitron Bioptics, LLC2016-04-01
Affirm Prone Biopsy System (K153486)Hologic, Inc.2016-04-01
NewTom VGi evo (K151612)Qr S.R.L.2016-03-31
ECHELON Oval V 5.1 MRI System (K153547)Hitachi Medical Systems America, Inc.2016-03-31
MAGNETOM Spectra (K153447)Siemens Medical Solutions USA, Inc.2016-03-31
Visaris Vision® (Vision C, Vision U. Vision V, Vision X) (K160620)Visaris D.O.O. Belgrade2016-03-30
SIGNAPioneer (K160621)GE Healthcare2016-03-29
Synaptive ImageDrive Pro (K153284)Synaptive Medical, Inc.2016-03-29
LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 (K160277)GE Medical Systems Ultrasound and Primary Care Diagnostics2016-03-25
SOMATOM Perspective (K151765)Siemens Medical Solutions USA, Inc.2016-03-25
EV Insite System (K152716)Psp Corporation2016-03-24
Ingenia 1.5T and Ingenia 1.5T S R5.2 (K153324)Philips Medical Systems Nederlands B.V.2016-03-22
D-SPECT Processing and Reviewing Workstation (K160120)Spectrum Dynamics , Ltd.2016-03-21
SpeqT (K160420)Signostics Limited2016-03-21
Tuxedo Digital Dental Sensor (K153710)Led Dental, Inc.2016-03-18
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) (K151749)Siemens Medical Solutions USA, Inc.2016-03-18
FibroScan 530 Compact (K160524)Echosens2016-03-18
Xeleris 4.0 Processing and Review Workstation (K153355)GE Healthcare2016-03-16
FUJIFILM FC1 Ultrasound System (K160406)FUJIFILM Sonosite, Inc.2016-03-16
Vitrea CT Colon Analysis (K160150)Vital Images, Inc.2016-03-16
ArthrexVIP Web Portal (K153612)Custom Orthopaedic Solutions, Inc.2016-03-15
Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, (K153119)Summit Industries, LLC2016-03-14
CAAS Workstation (K151780)Pie Medical Imaging BV2016-03-11
Vivid T8 (K160078)Ge Medical Systems Ultrasound and Primary Care Diagnotics, L2016-03-10
TE7 Diagnostic Ultrasound System (K160381)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2016-03-09
SmartView 3D Option (K153429)Ge Hangwei Medical System Co., Ltd.2016-03-09
TruGuard Custom Tongue and Jaw Positioner (K153270)Bionix Development Corp.2016-03-08
Cios Fusion (K153244)Siemens Medical Solutions USA, Inc.2016-03-07
Platinum dRF Imaging System (K160301)Apelem-Dms Group2016-03-04
syngo.via MI Workflows (K160426)Siemens Medical Solutions USA, Inc.2016-03-04
Sheathes Ultrasound Probe Covers (K153212)Sheathing Technologies, Inc.2016-03-04
syngo Application Software VD11 (K153346)Siemens Medical Solutions USA, Inc.2016-03-04
Olea Sphere V3.0 (K152602)Olea Medical2016-03-03
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (K160347)Qingdao Hisense Medical Equipment Co., Ltd.2016-03-03
Wrist 3 (K160185)Aspect Imaging, Ltd.2016-03-01
syngo.via MI Workflows (K160317)Siemens Medical Solutions USA, Inc.2016-02-29
LOGIQ S7 Expert (K160182)GE Healthcare2016-02-26
VIVIX-S 1717N (K152894)Vieworks Co., Ltd.2016-02-26
E-CUBE i7 (K153424)Alpinion Medical Systems Co., Ltd.2016-02-26
VIVIX-S 1012N (K152855)Vieworks Co., Ltd.2016-02-26
Axxent Electronic Brachytherapy System Model 110 XP 1200 (K153570)Icad, Inc.2016-02-25
MRCAT (K151435)Philips Medical Systems MR Finland2016-02-25
DIVA ZSP2105CMI with QUBYX PerfectLum bundle (K160328)The Linden Group Corp2016-02-25
MedicVOD System (K151737)Orpheus Medical , Ltd.2016-02-25
IMPLANT 3D (K153091)Media Lab S.R.L.2016-02-25
Voluson S6, Voluson S8, Voluson S10 (K160184)GE Healthcare2016-02-25
McLaren Proton Therapy System (K160063)Mclaren Health Care Corporation2016-02-25
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR (K160247)Eizo Corporation2016-02-23
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) (K160326)Jvckenwood Corporation2016-02-23
FS-PACS (K152034)Ec-Web Co., Ltd.2016-02-23
syngo.CT Single Source Dual Energy (Twin Beam) (K153220)Siemens Medical Solutions USA, Inc.2016-02-19
I4 (Integrated Intelligent Imaging Informatics) system (K160315)Philips Medical Systems Nederland B.V.2016-02-19
DBSWIN and VistaEasy Imaging Software (K143290)Durr Dental AG2016-02-18
CliniscanSM MRI (K153593)Picofemto, LLC2016-02-17
NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (K153479)Ninepoint Medical, Inc.2016-02-16
Radiance V3 (K153368)Gmv Soluciones Globales Internet S.A.U.2016-02-16
TraumaCad Mobile Release 2.0 (K160001)Voyant Health, Ltd.2016-02-12
Clear Guide SCENERGY (K153004)Clear Guide Medical2016-02-12
CARESTREAM Vue PACS (K153103)Carestream Health, Inc.2016-02-12
Cios Select (K153232)Siemens Medical Solutions USA, Inc.2016-02-10
ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray (K152489)Panoramic Corp.2016-02-04
Adaptivo (K152994)Aurora Technology Development, LLC2016-02-03
Synapse PACS (K160108)Fujifilm Medical Systems U.S.A, Inc.2016-02-03
HF1202H PowerPlus Portable X-ray Equipment (K153059)Minxray, Inc.2016-02-02
WS80A Diagnostic Ultrasound System (K153529)Samsung Medison Co., Ltd.2016-02-02
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