Atlas FDA

Radiology

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
OmniTom (K171183)Neurologica Corporation2017-08-18
Acclarix AX4 Diagnostic Ultrasound System (K171900)Edan Instruments, Inc.2017-08-18
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) (K163500)Ion Beam Applications S.A.2017-08-17
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems (K172162)Siemens Healthcare2017-08-16
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System (K172374)Siemens Medical Solutions USA, Inc.2017-08-15
Eclipse Treatment Planning System (K172163)Varian Medical Systems, Inc.2017-08-15
SmartUs EXT-1M/3M (K163121)Telemed2017-08-10
OEC Elite (K171565)Ge Oec Medical Systems, Inc.2017-08-10
WS80A Diagnostic Ultrasound System (K171070)Samsung Medison Co., Ltd.2017-08-09
HS40 Diagnostic Ultrasound System (K172129)Samsung Medison Co., Ltd.2017-08-08
U-Lite EXP (K171164)Sonoscanner2017-08-03
Clarity Reveal (K171356)Ceevra, Inc.2017-08-03
Scanmate Flex (K171301)Dgh Technology, Inc.2017-07-31
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range (K171040)Koelis2017-07-31
NovaPACS (K171754)Novarad Corporation2017-07-28
Smart Stitching Software System, Image Processing, Radiological (K163048)Osko, Inc.2017-07-28
VitalBeam (K172013)Varian Medical Systems, Inc.2017-07-28
NHAC 16 (K171515)Lmt Medical Systems GmbH2017-07-26
BiopSee, Mobile US (K170841)Medcom GmbH2017-07-26
HP PRO Positioning Device (K171734)Orfit Industries NV2017-07-25
TomoTherapy Treatment Delivery System with iDMS (K171837)Accuray Incorporated2017-07-25
Radiance V4 (K171885)Gmv Soluciones Globales Internet S.A.U.2017-07-25
YELLOW 560 Fluorescence Module (K162991)Carl Zeiss Meditec, AG2017-07-24
Vantage Elan 1.5T, V4.0 (K171597)Toshibamedical Systems Corporation2017-07-21
Ultimax-i, DREX-UI80 V1.60 (K170832)Toshibamedical Systems Corporation2017-07-21
Vitrea View (K163232)Vital Images, Inc.2017-07-21
Embrace Neonatal MRI System (K170978)Aspect Imaging, Ltd.2017-07-19
XPress BCD Breast Compression Device (K163388)Xpress Bcd, LLC2017-07-19
OLINDA EXM (K163687)Hermes Medical Solutions AB2017-07-19
QuantX (DEN170022)Quantitative Insights, Inc.2017-07-19
Nio Color 2MP (MDNC-2123) (K171812)Barco N.V.2017-07-19
Examion X-AQS (K170729)Examion GmbH2017-07-18
Arterys Viewer (K171544)Arterys, Inc.2017-07-18
Faxitron Bioptics Speciemen Radiography System (K170786)Faxitron Bioptics, LLC2017-07-18
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System (K171824)Edan Instruments, Inc.2017-07-18
3D Endo Software (K171115)Dentsply Sirona2017-07-17
!M1 (K170607)Solutions For Tomorrow AB2017-07-17
SIGNA Premier (K171128)Ge Medical Systems, LLC2017-07-14
RTHawk, HeartVista Cardiac Package (K170090)Heartvista, Inc.2017-07-14
Acuson SC2000 Diagnostic Ultrasound System (K171766)Siemens Medi Cal Solutions, Inc.2017-07-12
P50 Series Digital Color Doppler Ultrasound System (K170999)Sonoscape Medical Corp.2017-07-12
OEC Elite MiniView (K171800)Ge Hualun Medical Systems Co. , Ltd.2017-07-12
TrueBeam, TrueBeam STx, Edge (K171733)Varian Medical Systems, Inc.2017-07-12
AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (K171105)Supersonic Imagine2017-07-11
P60 Series Digital Color Doppler Ultrasound System (K171000)Sonoscape Medical Corp.2017-07-11
Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories (K171133)Qfix2017-07-11
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System (K171034)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-07-10
Models 3543A, 4343A, 2929A and A843B (K170480)Shanghai PZ Medical Technolgoy Co., Ltd.2017-07-07
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems (K171461)Philips Medical Systems Dmc GmbH2017-07-07
Site~Rite Halcyon Diagnostic Ultrasound System (K170870)Chison Medical Imaging Co., Ltd.2017-07-06
Eclipse Treatment Planning System (K170969)Varian Medical Systems, Inc.2017-07-05
Leica FL560 (K170239)Leica Microsystems (Schweiz) AG2017-07-05
Enterprise Imaging XERO Viewer 8.1 (K170434)Agfa Healthcare N.V.2017-07-03
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 (K170177)Toshibamedical Systems Corporation2017-06-30
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) (K163624)Fujifilm Medical Systems U.S.A, Inc.2017-06-30
RayStation (K171536)RaySearch Laboratories AB (PUBL)2017-06-27
Halcyon (K170817)Varian Medical Systems, Inc.2017-06-27
SUITESTENSA (K163668)Ebit Srl2017-06-23
CUBEScan™ BioCon-900 (Bladder Volume Measurement System) (K171591)Mcube Technology Co., Ltd.2017-06-22
Retina Workplace (K170638)Carl Zeiss Meditec, AG2017-06-21
Venue (K170714)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017-06-21
BSD4343R Digital Flat Panel X-ray Detector (K171485)Bontech, Inc.2017-06-21
DRX-Revolution Nano Mobile X-ray System (K170755)Carestream Health, Inc.2017-06-21
Green16/Green18 (Model: PHT-65LHS) (K170066)VATECH Co., Ltd.2017-06-16
Infinix INFX-8000V, V6.40 (K170909)Toshiba Medical Systems Coroporation2017-06-16
EchoPAC Software Only, EchoPAC Plug-in (K170847)GE Medical Systems Ultrasound and Primary Care Diagnostics2017-06-14
MAGNETOM Vida (K170396)Siemens Medical Solutions USA, Inc.2017-06-14
BodyTom Elite (K170238)Neurologica Corporation, A Subsidiary of Samsung Electronics2017-06-14
Vivid S60N, Vivid S70N (K170878)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017-06-14
SonoSite X-Porte Ultrasound System (K171437)FUJIFILM Sonosite, Inc.2017-06-12
1417WCC_127um and1417WCC_140um (K171418)Rayence Co., Ltd.2017-06-12
Vivid E80, Vivid E90, Vivid E95 (K170823)GE Medical Systems Ultrasound and Primary Care Diagnostics2017-06-12
1417WGC_127um and 1417WGC_140um (K171417)Rayence Co., Ltd.2017-06-12
MELODY, Remote Control System for Ultrasound Probe (K161354)Adecho Tech2017-06-12
1717SGC_127um and 1717SGC_140um (K171419)Rayence Co., Ltd.2017-06-09
syngo Application Software (K170747)Siemens Medical Solutions USA, Inc.2017-06-09
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor (K163313)CIVCO Medical Instruments Co., Inc.2017-06-09
1717SCC_127um and 1717SCC_140um (K171420)Rayence Co., Ltd.2017-06-09
Accuray Precision Treatment Planning System (K171086)Accuray Incorporated2017-06-08
Vitrea Software Toshiba Package; VSTP-001A (K171222)Toshibamedical Systems Corporation2017-06-08
Vantage Titan 1.5T, MRT-1510, M-Power GX (K170412)Toshibamedical Systems Corporation2017-06-07
CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris (K171353)Minxray, Inc.2017-06-07
StentBoost Live (K170144)Philips Medical Stystems Nederland BV2017-06-07
SmartTarget (K170250)Smarttarget, Ltd.2017-06-07
MRIdian Linac System with 138-leaf Collimator (K170751)Viewray, Incorporated2017-06-07
SonoBook Series Diagnostic Ultrasound System (K170374)Chison Medical Imaging Co., Ltd.2017-06-06
QT Ultrasound Breast Scanner-1 (K162372)Qt Ultrasound, LLC2017-06-06
Revolution ACT (K171013)Ge Hangwei Medical Systems Co., Ltd.2017-06-05
Dynamic Coronary Roadmap (K170130)Philips Medical Systems Nederland B.V.2017-06-02
Biograph Horizon PET/CT (K170904)Siemens Medical Solutions USA, Inc.2017-06-01
System, Applicator, Radionuclide, Remote Controlled (K170203)Kobold, LLC2017-06-01
Celesteion, PCA-9000A/3 (K170490)Toshibamedical Systems Corporation2017-06-01
syngo Dynamics Version VA30 (K171053)Siemens Healthcare GmbH2017-06-01
OARtrac System with Patient Specific Reusable Universal PSD Sensors (K162954)Radiadyne, LLC2017-06-01
GTK Disposable Needle Guides (K170741)Geotek Medikal Ltd Sti2017-06-01
QLAB Advanced Quantification Software (K171314)Philips Health Care2017-05-30
AmCAD-US (K162574)Amcad Biomed Corporation2017-05-30
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (K163702)Toshibamedical Systems Corporation2017-05-30
ARIETTA PRECISION (K163505)Hitachi , Ltd.2017-05-30
TRINITY/3D PROSTATE SUITE (K170521)Koelis2017-05-30
← Previous Next →

Track Radiology automatically

Every clearance here is in the API, with alerts when new ones post.