Atlas FDA

Radiology

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

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RecordFirmDate
CAAS Workstation (K180019)Pie Medical Imaging BV2018-05-03
Venue (K180599)GE Medical Systems Ultrasound and Primary Care Diagnostics2018-05-02
ExactVu High Resolution Micro-Ultrasound System (K180636)Exact Imaging, Inc.2018-04-30
HDR MRI Lumen Marker (K180069)C4 Imaging, LLC2018-04-27
hipEOS (K173390)Onefit Medical2018-04-27
VERITON NM (K180514)Spectrum Dynamics Medical, Ltd.2018-04-25
RayStation 7 (K180379)RaySearch Laboratories AB (PUBL)2018-04-25
syngo.plaza (K180563)Siemens Healthcare GmbH2018-04-25
IMACTIS CT-Navigation system (K162314)Imactis, Sas2018-04-24
ZOOM (K172768)Zetta Medical Technologies, LLC2018-04-24
GSI Viewer with GSI Fat Option (K180225)GE Medical Systems SCS2018-04-24
trophon2 (K173865)Nanosonics Limited2018-04-24
Aria (K180782)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2018-04-20
Televere Podiatry X-Ray System HF (K180765)Televere Systems, Inc.2018-04-20
Viz CTP (K180161)Viz. Ai, Inc.2018-04-20
Viamo c100 TUS-VC100 Diagnostic Ultrasound System (K173962)Toshibamedical Systems Corporation2018-04-20
syngo.MR Applications (K180336)Siemens Medical Solutions USA, Inc.2018-04-19
iSchemaView RAPID (K172477)Ischemaview, Inc.2018-04-19
NM/CT 850, NM/CT 860 (K173816)GE Healthcare2018-04-17
uMI 780 PET/CT System (K172143)Shanghai United Imaging Healthcare Co., Ltd.2018-04-13
SmartGrid (K180667)Carestream Health, Inc.2018-04-13
SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO (K173632)Siemens Medical Solutions USA, Inc.2018-04-13
SonoSite iViz Ultrasound System (K180704)FUJIFILM Sonosite, Inc.2018-04-13
LIGHTSonic BUBM (K170761)Lightmed USA, Inc.2018-04-13
U60 Diagnostic Ultrasound System (K180408)Edan Instruments, Inc.2018-04-13
Best Instruminal Applicator (K162499)Best Medical International, Inc.2018-04-13
48CH Head Coil (K180666)Ge Healthcare Coils (Usa Instruments, Inc.)2018-04-12
Uroview FD II (K180651)Pausch Medical GmbH2018-04-12
ZED Link (K180549)Zed Technologies2018-04-12
PET Digital Gating (K180318)Ge Medical Systems, LLC2018-04-11
s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System (K173860)Volcano Corporation2018-04-11
Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung (K170570)Varian Medical Systems, Inc.2018-04-06
DR 800 with MUSICA Dynamic (K180589)Agfa Healthcare N.V.2018-04-05
Corin Optimized Positioning System (OPS™) Plan (K171847)Corin U.S.A. Limited2018-04-05
syngo.via MI Workflows (K173897)Siemens Medical Solutions USA, Inc.2018-04-05
PowerLook Density Assessment Software (K180125)Icad, Inc.2018-04-05
uWS-MI (K172998)Shanghai United Imaging Healthcare Co., Ltd.2018-04-05
GammaPod (K180571)Xcision Medical Systems, LLC2018-04-04
SIMPLANT 18 (K172239)Dentsply Sirona2018-04-04
SciMoCa (K180595)Radialogica, LLC2018-04-04
Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 (K173079)Philips Medical Systems Nederland B.V.2018-04-04
Scenium VE20 Software (K173597)Siemens Medical Solutions USA, Inc.2018-04-04
Varian Head Frame (K180586)Varian Medical Systems, Inc.2018-04-02
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (K173639)Siemens Medi Cal Solutions, Inc.2018-04-02
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence (K173630)Siemens Medical Solutions USA, Inc.2018-03-30
MAGNETOM Vida with Compressed Sensing GRASP-VIBE (K173617)Siemens Medical Solutions USA, Inc.2018-03-30
G-scan Brio (K180592)Esaote, S.p.A.2018-03-30
syngo.CT Coronary Analysis; syngo.CT Vascular Analysis (K173637)Siemens Medical Solutions USA, Inc.2018-03-30
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (K173789)Elekta Instrument AB2018-03-30
RADspeed fit (K173517)Shimadzu Corporation2018-03-30
Vitrea Software Package; VSTP-001A (K180323)Canon Medical Systems Corporation2018-03-30
Voluson P6 and Voluson P8 (K180535)GE Healthcare2018-03-29
Prelude (K180308)Medcom GmbH2018-03-27
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR (K180473)Ecotron Co., Ltd.2018-03-23
SRT-100+ (K173425)Sensus Healthcare, Inc.2018-03-23
MED-TAB (K173241)Plum Medical Solutions GmbH2018-03-23
Mimics inPrint (K173619)Materialise NV2018-03-21
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths (K172611)Varian Medical Systems, Inc.2018-03-21
Mammomat Revelation (K173408)Siemens Medi Cal Solutions, Inc.2018-03-21
WillCeph (K172168)Hdx Will Corp.2018-03-21
SOMATOM Edge Plus (K173607)Siemens Medical Solutions USA, Inc.2018-03-21
Emprint Ablation Visualization Application (K180192)Covidien, LLC2018-03-21
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil (K163661)Rapid Biomedical GmbH2018-03-21
Philips Incisive CT (K180015)Philips Healthcare (Suzhou) Co., Ltd.2018-03-20
Ingenia Elition S and Ingenia Elition X (K173451)Philips Medical Systems Nederland B.V.2018-03-20
Imbio Segmentation Editing Tool software (K180129)Imbio, LLC2018-03-16
syngo Application Software (K173611)Siemens Medical Solutions USA, Inc.2018-03-16
AIRO Computed Tomography (CT) X-ray System (K180393)Mobius Imaging, LLC2018-03-15
MR Wireless Gating System, Model WGS-100 (K171778)Ivy Biomedical Systems, Inc.2018-03-14
ThinkQA (K180106)Dosisoft2018-03-13
Voluson S8/ Voluson S10/ Voluson S10 Expert (K180374)GE Healthcare2018-03-13
SICAT Endo (K180262)Sicat GmbH & Co. KG2018-03-12
BrightMatter Plan 1.6.0 (K180394)Synaptive Medical, Inc.2018-03-09
Quantib Brain (K173939)Quantib B.V.2018-03-09
HS70A Diagnostic Ultrasound System (K173713)Samsung Medison Co., Ltd.2018-03-08
icobrain (K180326)Icometrix2018-03-08
iQMR (K173605)Medic Vision - Imaging Solutions, Ltd.2018-03-08
syngo.CT Clinical Extensions (K173625)Siemens Medical Solutions USA, Inc.2018-03-08
Ingenia Elition S and Ingenia Elition X R5.4 (K173356)Philips Medical Systems Nederland B.V.2018-03-06
ProBx Software (K173312)Harmonus, Inc.2018-03-02
SoftVue (K172256)Delphinus Medical Technologies2018-03-02
COMPACT TOUCH Ophthalmic Ultrasound System (K180265)Quantel Medical2018-03-02
uCT Computed Tomography X-ray System (K172135)Shanghai United Imaging Healthcare Co., Ltd.2018-03-02
TrackX (K173736)Track X Technology, LLC2018-02-28
Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) (K172750)Guangzhou Sonostar Technologies Co., Ltd.2018-02-28
CereMetrix Silver (K173145)Ceremetrix Corp2018-02-28
ALOKA ARIETTA 850 (K173739)Hitachi Healthcare Americas Corporation2018-02-28
Ophthalmic Software Platform RX (K173689)Canon Inc. -Medical Equipment Group2018-02-23
SPIN-SWI (K173224)Spintech, Inc.2018-02-23
DM-Density (K170540)Densitas, Inc.2018-02-23
Ez3D-i /E3 (K173863)Ewoosoft Co., Ltd.2018-02-23
Ultrasound System 1300 (K173569)Bk Medical Aps2018-02-23
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 (K173468)Toshibamedical Systems Corporation2018-02-23
WS80A Diagnostic Ultrasound System (K173513)Samsung Medison Co., Ltd.2018-02-20
Wireless Audio System (K173409)Neocoil, LLC2018-02-16
Breast BI 7 MR Coil 1.5T Mammavention (K180123)Noras Mri Products GmbH2018-02-16
Velocity (K173636)Varian Medical Systems, Inc.2018-02-15
CT6485, CT12885 (K172058)Analogic Corporation2018-02-13
ContaCT (DEN170073)Viz.Al, Inc.2018-02-13
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit (K173592)Siemens Medical Solutions USA, Inc.2018-02-13
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