Atlas FDA

Radiology

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

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RecordFirmDate
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System (K163140)Gemss Medical Systems Co., Ltd.2017-05-26
FFR V2.5 (K170133)Philips Volcano2017-05-26
DELL UP3017 with QUBYX PerfectLum bundle (K171229)Qubyx Software Technologies, Inc.2017-05-26
LCD Monitor (MD310C, MD310G, MD210G) (K170944)Benq Corporation2017-05-25
UNiD Spine Analyzer (K170172)Medicrea International2017-05-24
AS-10, CXDI-401RF (K171194)Canon, Inc.2017-05-24
vascuCAP (K163071)Elucid Bioimaging, Inc.2017-05-24
Pinpoint GT Needle Guide Kits (K171348)C.R. Bard, Inc.2017-05-22
Hybrid3D (K163394)Hermes Medical Solutions AB2017-05-22
OEC Elite (K170752)Oec Medical Systems, Inc.2017-05-19
BEAMSCAN (K161807)Ptw-Freiburg Physikalisch Technische-Werksraetten2017-05-19
E5 Series Digital Color Doppler Ultrasound System (K170303)Sonoscape Medical Corp.2017-05-19
QuantX (K170195)Quantitative Insights, Inc.2017-05-17
Dynamika (K161601)Image Analysis Limited2017-05-17
Nexus DR Digital X-ray Imaging System (K171138)Varex Imaging Corporation2017-05-17
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley (K170078)Medisono, LLC2017-05-17
iSR'obot Biopsy Kit (K163502)Biobot Surgical Pte., Ltd.2017-05-16
A-View (K170338)Stroke2prevent B.V.2017-05-16
SPiN Thoracic Navigation System (K170023)Veran Medical Technologies, Inc.2017-05-15
EVS 2430W, EVS 2430GW (K171137)DRTECH Corporation2017-05-15
GM85 (K171119)Samsung Electronics Co., Ltd.2017-05-12
SurgiCase Viewer (K170419)Materialise NV2017-05-11
Lung Vision (K163622)Bodyvision Medical , Ltd.2017-05-11
Longitudinal Brain Imaging (LoBI) application (K163250)Philips Medical Systems Nederland B.V.2017-05-11
GMR40 (K171085)Neurologica Corporation, A Subsidiary OF2017-05-11
Ablation Confirmation (K171022)Neuwave Medical, Inc.2017-05-09
Will3D (K170180)Hdx Will Corp.2017-05-08
In Reach (K170789)Curvebeam, LLC2017-05-05
Nucleus Image Management System (K171130)Nucleushealth, LLC2017-05-04
AXIS Image Management System (K171098)Sonomed, Inc.2017-05-02
NuVasive NuvaLine Mobile App (K162647)Nu Vasive, Incorporated2017-05-01
Televere Digital Imaging System (K170975)Televere Systems2017-05-01
NaviSuite SSI Edition (K163119)Medcom GmbH2017-05-01
syngo.CT View&GO (K170952)Siemens Medical Solutions USA, Inc.2017-04-28
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) (K161724)Radiomed Corporation2017-04-28
Z-DOSE29 (K170273)Zetta Medical Technologies, LLC2017-04-28
RadiForce MX315W (K170949)Eizo Corporation2017-04-27
RSM 2430C (K170930)DRTECH Corporation2017-04-27
AmCAD-UV (K170069)Amcad Biomed Corporation2017-04-26
Cliniview (K162799)Palodex Group OY2017-04-25
FDR AQRO (DR-XD 1000) (K170858)Fujifilm Medical Systems U.S.A, Inc.2017-04-24
syngo.CT Cardiac Planning (K170221)Siemens Healthcare GmbH2017-04-21
PercuNav Image Fusion and Interventional Navigation (K170716)Philips Ultrasound, Inc.2017-04-21
HyperSense (K162722)Ge Medical Systems, LLC2017-04-20
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K163690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-04-20
Interson USB Ultrasound System (K163443)Interson Corporation2017-04-13
Patient Positioning System (K170502)Forte Automation Systems, Inc.2017-04-13
Carestream Vue PACS (K170580)Carestream Health, Inc.2017-04-11
LOGIQ S8 (K170445)GE Healthcare2017-04-11
CyberKnife Treatment Delivery System (K170788)Accuray Incorportaed2017-04-11
Comfort EC710 (K163192)Alltech Medical Systems America, Inc.2017-04-10
Philips iCT CT System (K162838)Philips Medical Systems (Cleveland), Inc.2017-04-07
ORTHOPANTOMOGRAPH OP 3D (K170813)Palodex Group OY2017-04-07
CORE M2 Vascular System (K170385)Volcano Corporation2017-04-06
Huvitz Imaging System (K161829)Huvitz Co., Ltd.2017-04-06
Synapse 3D Perfusion Analysis (K162287)Fujifilm Medical Systems U.S.A, Inc.2017-04-06
Anzai Respiratory Gating System (K170719)Anzai Medical Co., Ltd.2017-04-05
LIFESYS PACS (K161341)Lifetrack Medical Systems, Inc.2017-04-05
Segment CMR (K163076)Medviso AB2017-04-05
Nio Color 3MP (MDNC-3421) (K170837)Barco N.V.2017-04-05
IQon Spectral CT (K163711)Philips Medical Systems (Cleveland), Inc.2017-04-05
UltraScan 650 (K161919)Cyberlogic, Inc.2017-04-05
Acuson SC2000 Diagnostic Ultrasound System (K170315)Siemens Medi Cal Solutions, Inc.2017-04-04
MX50N(MX50YQS) (K170781)Wide Corporation2017-04-04
Move Forward 3D Motion Simulation Service (K162559)Biomet, Inc.2017-03-31
CX50N(CX50YQS) (K170783)Wide Corporation2017-03-31
HS50 / HS60 Diagnostic Ultrasound System (K170493)Samsung Medison Co., Ltd.2017-03-28
Nio Color 5.8MP (MDNC-6121) (K170476)Barco N.V.2017-03-28
Mould Applicator Set (K162615)Varian Medical Systems, Inc.2017-03-24
Scan&GO (K163297)Siemens Medical Solutions USA, Inc.2017-03-24
INFINITT ULite (K163290)Infinitt Co., Ltd.2017-03-24
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System (K170277)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-03-23
360KS Implant Positioning System (K163405)Kico Knee Innovation Company Pty Limited2017-03-21
SOMATOM go.Up, SOMATOM go.Now (K163296)Siemens Medical Solutions USA, Inc.2017-03-21
SmartGrid (K163157)Carestream Health2017-03-21
Exam Vue PACS (K162868)Jpi Healthcare Solutions, Inc.2017-03-17
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (K163331)Ge Medical Systems, LLC2017-03-17
FDX Console (DR-ID300CL) Software (K170451)Fujifilm Medical Systems U.S.A, Inc.2017-03-16
6200 Ultrasound System and 6250 Ultrasound System (K163082)Esaote, S.p.A.2017-03-16
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source (K163572)Lv Liberty Vision Corp.2017-03-15
Interstitial Needles (K160815)Varian Medical Systems, Inc.2017-03-10
ARTIS pheno (K163286)Siemens Medical Solution USA, Inc.2017-03-09
CRC-77tHR (K162394)Capintec, Inc.2017-03-08
True 3D Viewer Software (K170167)Echopixel, Inc.2017-03-03
TheraView TBI (K170058)Cablon Medical B.V.2017-03-03
DigiX FDX (K162529)Allengers Medical Systems Limited2017-03-03
HITACHI Supria Whole-body X-ray CT System Phase 3 (K163528)Hitachi Medical Systems America, Inc.2017-03-03
RayStation 6 (K170355)RaySearch Laboratories AB (PUBL)2017-03-02
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS (K170332)Canon, Inc.2017-03-01
syngo. CT Neuro Perfusion (K163284)Siemens Medical Solutions USA, Inc.2017-03-01
Surface Applicator Set (K162018)Varian Medical Systems, Inc.2017-02-28
Biograph mMR with syngo MR E11P system software (K163234)Siemens Medical Solutions USA, Inc.2017-02-28
HF 718BD X-Ray System (K160857)Arquilla, Inc. Dba X-Cel X-Ray Corporation2017-02-24
The ViewRay (MRIdian) Linac System (K162393)Viewray, Incorporated2017-02-24
Lung Nodule Assessment and Comparison Option (LNA) (K162484)Philips Medical Systems Nederland B.V.2017-02-23
Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 (K163688)Medisono, LLC2017-02-23
RSM 1824C with RConsole1 (K162670)DRTECH Corporation2017-02-23
HS70A Diagnostic Ultrasound System (K163691)Samsung Medison Co., Ltd.2017-02-22
Aquarius 8600 (K170202)Imaging Dynamics Company , Ltd.2017-02-22
SIGNA PET/MR (K163619)Ge Medical Systems, LLC2017-02-14
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