Radiology · 2020Radiology AI devices by month in 2020: Jan 3, Feb 10, Mar 12, Apr 5, May 5, Jun 10, Jul 13, Aug 8, Sep 10, Oct 7, Nov 9, Dec 7
FDA-cleared AI devices for radiology 2020
2020 has 99 radiology AI devices, 94.1% more than 2019 (51). That is 8% of the 1,230 radiology devices on the FDA list, and 86.8% of all AI-device decisions dated 2020. The most active were Siemens Medical Solutions USA, Inc. (9), Canon Medical Systems Corporation (5), Shanghai United Imaging Healthcare Co., Ltd. (4). The newest is BriefCase from Aidoc Medical, Ltd., decided on December 29, 2020.
992020 devices
68Companies
86.8%Of all 2020 AI devices
8%Of all radiology
Companies in 2020
By month
JanFebMarAprMayJunJulAugSepOctNovDec
Product codes
LLZSystem, Image Processing, Radiological21JAKSystem, X-Ray, Tomography, Computed13QASRadiological Computer-Assisted Triage And Notification Software12QIHAutomated Radiological Image Processing Software11LNHSystem, Nuclear Magnetic Resonance Imaging8IYNSystem, Imaging, Pulsed Doppler, Ultrasonic7QFMRadiological Computer-Assisted Prioritization Software For Lesions4QKBRadiological Image Processing Software For Radiation Therapy4All 99 devices
- BriefCaseAidoc Medical, Ltd. · Radiology
- AI MetricsAI Metrics, LLC · Radiology
- EchoGo ProUltromics Ltd · Radiology
- Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-ICanon Medical Systems Corporation · Radiology
- Deep Learning Image Reconstruction for Gemstone Spectral ImagingGE Medical Systems, LLC · Radiology
- HepaFat-AIResonance Health Analysis Services Pty Ltd · Radiology
- HealthJOINTZebra Medical Vision Ltd. · Radiology
- Revolution AscendGE Healthcare Japan Corporation · Radiology
- CorInsights MRIADM Diagnostics, Inc. · Radiology
- HALONICo-Lab B.V. · Radiology
- Genius AI DetectionHologic, Inc. · Radiology
- syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- PROViewGE Medical Systems SCS · Radiology
- FastStroke, CT Perfusion 4DGE Medical Systems SCS · Radiology
- AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc. · Radiology
- Neuro.Al AlgorithmTeraRecon, Inc. · Radiology
- WRDensity by Whiterabbit.aiWhiterabbit.ai Inc. · Radiology
- AutoContourRadformation, Inc. · Radiology
- A View LCSCoreline Soft Co., Ltd. · Radiology
- SIGNA 7.0TGE Medical Systems, LLC · Radiology
- Quantib ProstateQuantib BV · Radiology
- Cleerly Labs v2.0Cleerly, Inc. · Radiology
- LiverMultiScanPerspectum LTD · Radiology
- THINQCorticoMetrics LLC · Radiology
- LVivo SeamlessDiA Imaging Analysis Ltd · Radiology
- Xeleris V Processing and Review SystemsGE Healthcare · Radiology
- RayStationRaySearch Laboratories AB (publ) · Radiology
- Caption GuidanceCaption Health · Radiology
- EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- AVA (Augmented Vascular Analysis)See-Mode Technologies Pte. Ltd. · Radiology
- Vivid iqGE Medical Systems Ultrasound and · Radiology
- Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- SIGNA ArtistGE Healthcare (Tianjin) Company Limited · Radiology
- BriefCaseAidoc Medical, Ltd. · Radiology
- AVIEWCoreline Soft Co., Ltd · Radiology
- TOMTEC-ARENATOMTEC Imaging Systems GmbH · Radiology
- Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc. · Radiology
- Limbus ContourLimbus AI Inc. · Radiology
- VIDAvisionVIDA Diagnostics Inc. · Radiology
- AccipiolxMaxQ Al Ltd. · Radiology
- HYPER DLRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- FractureDetect (FX)Imagen Technologies, Inc. · Radiology
- AI-Rad Companion Prostate MRSiemens Medical Solutions USA Inc. · Radiology
- Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and · Radiology
- Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · Radiology
- Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- HealthMammoZebra Medical Vision Ltd. · Radiology
- Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- AI-Rad Companion EngineSiemens Medical Solutions USA, Inc. · Radiology
- Ezra Plexo SoftwareEzra AI Inc. · Radiology
- Rapid LVOiSchemaView Inc. · Radiology
- Deep ReconShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Contour ProtegeAIMIM Software Inc. · Radiology
- InferRead Lung CT.AIBeijing Infervision Technology Co.,Ltd. · Radiology
- Rapid ASPECTSiSchemaView Inc. · Radiology
- CINAAVICENNA.AI · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd · Radiology
- BriefCaseAidoc Medical, Ltd. · Radiology
- qERQure.ai Technologies · Radiology
- AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · Radiology
- MEDO ARIAMedo.ai · Radiology
- Auto 3D Bladder Volume ToolButterfly Network, Inc. · Radiology
- QLAB Advanced Quantification SoftwarePhilips Healthcare · Radiology
- uWS-MRShanghai United Imaging Healthcare Co., Ltd · Radiology
- Syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · Radiology
- HealthVCFZebra Medical Vision Ltd. · Radiology
- uMR 780Shanghai United Imaging Healthcare Co., Ltd · Radiology
- AVIEW LCSCoreline Soft Co., Ltd · Radiology
- EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · Radiology
- NinesAINines, Inc. · Radiology
- Caption GuidanceCaption Health · Radiology
- CuraRad-ICHCuraCloud Corp. · Radiology
- SIGNA PremierGE Healthcare (GE Medical Systems, LLC) · Radiology
- AIMI-Triage CXR PTXRADLogics, Inc. · Radiology
- Rapid ICHiSchemaView Incorporated · Radiology
- KOSMOSEchoNous, Inc. · Radiology
- Arterys MICAArterys Inc. · Radiology
- MammoScreenTherapixel · Radiology
- Hepatic VCARGE Medical Systems SCS · Radiology
- Viz ICHViz.ai, Inc. · Radiology
- Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. · Radiology
- SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC · Radiology
- syngo.CT Lung CADSiemens Medical Solutions, Inc · Radiology
- Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- TransparaScreenPoint Medical B.V. · Radiology
- BroncholabFluidda Inc. · Radiology
- icobrain-ctpIcometrix NV · Radiology
- Red DotBehold.AI Technologies Limited · Radiology
- AccuContourXiamen Manteia Technology LTD. · Radiology
- Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-iCanon Medical Systems Corporation · Radiology
- densitas densityaiDensitas, Inc. · Radiology
- Biograph Vision, Biograph mCT Family of PET/CTsSiemens Medical Solutions USA, Inc · Radiology
- Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging SystemCanon Medical Systems Corporation · Radiology
- Biograph HorizonSiemens Medical Solution USA, Inc. · Radiology
- Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc. · Radiology
- Caption GuidanceBay Labs, Inc. · Radiology
- MRCAT brainPhilips Medical Systems MR Finland · Radiology
- Auto PositioningGE Hangwei Medical Systems, Co., Ltd. · Radiology
- ADAS 3DGalgo Medical S.L · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2020?
99 AI-enabled radiology devices have a final decision dated 2020, from 68 companies.
How does 2020 compare with 2019 for AI radiology devices?
2020 has 99 radiology AI devices, 94.1% more than 2019 (51).
Which companies cleared the most AI radiology devices in 2020?
Siemens Medical Solutions USA, Inc. (9), Canon Medical Systems Corporation (5), Shanghai United Imaging Healthcare Co., Ltd. (4).
What was the most recent AI radiology device in 2020?
BriefCase from Aidoc Medical, Ltd. (K203508), decided on December 29, 2020. Product code QAS.
Which product codes were most common for AI radiology devices in 2020?
LLZ (System, Image Processing, Radiological): 21; JAK (System, X-Ray, Tomography, Computed): 13; QAS (Radiological Computer-Assisted Triage And Notification Software): 12.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2020,” https://ai-device-radar.vercel.app/specialty/radiology/2020 (FDA list through 2026-06-29).