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
CONTINUUM PACS (K200385)Integrated Ophthalmic Systems, Inc.2020-03-16
Al-Rad Companion (Musculoskeletal) (K193267)Siemens Medical Solutions USA, Inc.2020-03-16
OptikView GUP2103CMI (K191705)The Linden Group Corp2020-03-16
AnatomicAligner (K190767)The Methodist Hospital Research Institute D/B/A Houston2020-03-16
CS 9600 (K200183)Trophy2020-03-13
32HL512D (K192925)Lg Electronics.Inc2020-03-13
EzOrtho (K192888)Ewoosoft Co., Ltd.2020-03-13
SonoVision Ultrasound Imaging System (K192388)Tissue Differentiation Intelligence, LLC2020-03-12
RefleXion Medical Radiotherapy System (K190978)Reflexion Medical, Inc.2020-03-12
MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit (K192924)Siemens Medical Solutions USA, Inc.2020-03-11
syngo.CT Lung CAD (K193216)Siemens Medi Cal Solutions, Inc.2020-03-09
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR (K192574)Canon Medical Systems Corporation2020-03-09
DR 600 with Tomosynthesis (K193262)Agfa N.V.2020-03-09
EPIQ Diagnostic Ultrasound System (K200304)Philips Ultrasound, Inc.2020-03-06
Insight Enhanced DRF Digital Imaging System (K200396)Imaging Engineering, LLC2020-03-06
TrackX (K200360)Track X Technology, LLC2020-03-05
Kinepict Medical Imaging Tool version v2.2 (K190993)Kinepict Health, Ltd.2020-03-05
Transpara (K193229)Screenpoint Medical B.V.2020-03-05
ProVecta 3D Prime Ceph (K193139)Durr Dental SE2020-03-05
CURA 778 (K192590)Fmi Medical Systems, Inc.2020-03-05
Broncholab (K191550)Fluidda, Inc.2020-03-04
OVision Imaging System (K200275)Ophthalmic Labs, Inc.2020-03-03
Vantage Galan 3T, MRT-3020, V6.0 (K192506)Canon Medical Systems Corporation2020-03-02
icobrain-ctp (K192962)Icometrix NV2020-02-28
Red Dot (K191556)Behold.Ai Technologies Limited2020-02-28
Magnetom Sola, Magnetom Altea and Magnetom Sola Fit (K192496)Siemens Medical Solutions USA, Inc.2020-02-28
Alta Multipurpose Device (K193243)Qfix2020-02-28
AccuContour (K191928)Xiamen Manteia Technology , Ltd.2020-02-28
CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor (K200221)Mick Radio-Nuclear Instruments, Inc.2020-02-28
SonicEye Dual-Array Ultrasound System (K192253)Sonivate Medical, Inc.2020-02-25
uCT 530, uCT 550 (K200016)Shanghai United Imaging Healthcare Co., Ltd.2020-02-25
Ez3D-i /E3 (K200178)Ewoosoft Co., Ltd.2020-02-25
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i (K192832)Canon Medical Systems Corporation2020-02-21
OASIS MRI System (K192851)Hitachi Healthcare Americas2020-02-21
Beamscan MR (K191646)Ptw-Freiburg Physikalisch-Technische-Werkstaetten2020-02-21
3MP Monochrome Digital Mammography LCD Monitor MS-S300 (K200161)Jvckenwood Corporation2020-02-21
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K192922)Gentuity, LLC2020-02-20
densitas densityai (K192973)Densitas, Inc.2020-02-19
Vita Flex CR System with LLI (K192894)Carestream Health, Inc.2020-02-18
Collaboration Live (K200179)Philips Health Care2020-02-18
Ashvins (K200132)Medicalcommunications GmbH2020-02-18
Affinity (K193152)Hermes Medical Solutions AB2020-02-14
Biograph Vision, Biograph mCT Family of PET/CTs (K193248)Siemens Medical Solutions USA, Inc.2020-02-14
Vitrea Software Package (K192923)Canon Medical Systems Corporation2020-02-14
CardIQ Flow (K192277)GE Medical Systems SCS2020-02-14
ASCEND Image Viewer (K192372)Ascend Hit2020-02-14
E-COM DR-2000 DR (K193644)Livermoretech, Inc.2020-02-14
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System (K192828)Canon Medical Systems Corporation2020-02-13
Infinitt RT PACS (K193498)Infinitt Healthcare Co., Ltd.2020-02-13
Leltek Ultrasound Imaging System (K191235)Leltek, Inc.2020-02-12
Biograph Horizon (K193178)Siemens Medical Solution USA, Inc.2020-02-12
Acteon Imaging Suite (K192165)De Gotzen S.R.L.2020-02-11
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon (K192377)Varian Medical Systems, Inc.2020-02-10
Caption Guidance (DEN190040)Bay Labs, Inc.2020-02-07
Paragon XHD Diagnostic Ultrasound System (K191347)Shenzhen Wisonic Medical Technology Co. , Ltd.2020-02-07
Lucy Point-of-Care Magnetic Resonance Imaging Device (K192002)Hyperfine Research, Inc.2020-02-06
Akesis Galaxy RTx (K200050)Akesis, Inc.2020-02-04
Motion Correction System (K193324)Kineticor, Inc.2020-02-04
1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support (K191539)Rapid Biomedical GmbH2020-01-31
ACUSON Sequoia Diagnostic Ultrasound System (K193257)Siemens Medical Solutions USA, Inc.2020-01-31
HAD1717MC (K200018)H&Abyz2020-01-31
syngo.MR Applications (K192462)Siemens Medical Solutions USA, Inc.2020-01-31
Terason uSmart3200T Ultrasound System (K193510)Teratech Corporation2020-01-28
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System (K193637)Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.2020-01-28
Emission Computed Tomography System (K193241)Shanghai United Imaging Healthcare Co., Ltd.2020-01-26
THD Procto Software System (K193512)Thd Spa2020-01-26
MRCAT brain (K193109)Philips Medical Systems MR Finland2020-01-24
FlightPlan for Embolization (K193261)GE Medical Systems SCS2020-01-24
IQon Spectral CT (K193454)Philips Medical Systems Nederland B.V.2020-01-24
VistaScan USB Ultrasound Imaging System (K192170)Emagine Solutions Technology, LLC2020-01-23
Elements Viewer (K191014)Brainlab AG2020-01-23
VINNO 8, VINNO 6, VINNO 5 (K190120)Vinno Technology (Suzhou) Co.,Ltd2020-01-23
GammaTile (K190839)Gt Medical Technologies2020-01-23
Blue Phantom PT (K191821)Iba Dosimetry GmbH2020-01-23
Q-Rad System (K193574)Carestream Health, Inc.2020-01-22
EzMobile (K192098)Ewoosoft Co., Ltd.2020-01-20
Asimov-MKS Imaging System (K192761)Onlume, Inc.2020-01-17
C015 (K192182)Micronica Srl2020-01-17
Auto Positioning (K192956)Ge Hangwei Medical Systems Co., Ltd.2020-01-16
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography (K193225)Konica Minolta Healthcare Americas, Inc.2020-01-15
ADAS 3D (K191125)Galgo Medical S.L2020-01-15
ViewPoint 6 (K192917)Ge Medical Systems Ultrasound And2020-01-06
RS85 Diagnostic Ultrasound System (K192903)Samsung Medison Co., Ltd.2020-01-06
MRIaudio PREM System with MRIview (K193102)Mriaudio, Inc.2020-01-06
AlignRT Plus (K193431)Vision Rt, Ltd.2020-01-03
Flex Body SPEEDER (K193140)Quality Electrodynamics, LLC2020-01-03
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard (K193360)Radmedix, LLC2020-01-02
RadCalc Software (K193381)Lifeline Software, Inc.2019-12-31
AutoMIStar (K192912)Apollo Medical Imaging Technology Pty. , Ltd.2019-12-31
Volumetric Specimen Imager (K192939)Clarix Imaging2019-12-27
True 3D Viewer Software (K193149)Echopixel, Inc.2019-12-27
UroNav System (K193403)Invivo Corporation2019-12-27
Medical Radiation Dosimetry System microSTARii (K192196)Landauer2019-12-27
Ziehm Vision FD (K193230)Ziehm Imaging GmbH2019-12-20
MRopen EVO (K193116)Asg Superconductors S.P.A.2019-12-20
Nexus DR Digital X-Ray Imaging System (with vSharp) (K193238)Varex Imaging Corporation2019-12-20
AVIEW Modeler (K192040)Coreline Soft Co., Ltd.2019-12-20
QLAB Advanced Quantification Software (K191647)Philips Health Care2019-12-20
BriefCase (K192383)Aidoc Medical , Ltd.2019-12-20
DRX-Evolution with Carestream Digital Tomosynthesis (K191879)Carestream Health, Inc.2019-12-20
← Previous Next →

Track Radiology automatically

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