Radiology · 2021Radiology AI devices by month in 2021: Jan 8, Feb 7, Mar 12, Apr 10, May 4, Jun 6, Jul 11, Aug 10, Sep 14, Oct 7, Nov 8, Dec 13
FDA-cleared AI devices for radiology 2021
2021 has 110 radiology AI devices, 11.1% more than 2020 (99). That is 8.9% of the 1,230 radiology devices on the FDA list, and 85.3% of all AI-device decisions dated 2021. The most active were Canon Medical Systems Corporation (7), Siemens Medical Solutions USA, Inc. (5), Ge Medical Systems, LLC (4). The newest is LiverSmart from Resonance Health Analysis Services Pty Ltd, decided on December 29, 2021.
1102021 devices
83Companies
85.3%Of all 2021 AI devices
8.9%Of all radiology
Companies in 2021
By month
JanFebMarAprMayJunJulAugSepOctNovDec
Product codes
QIHAutomated Radiological Image Processing Software19LLZSystem, Image Processing, Radiological16IYNSystem, Imaging, Pulsed Doppler, Ultrasonic9JAKSystem, X-Ray, Tomography, Computed9QKBRadiological Image Processing Software For Radiation Therapy9LNHSystem, Nuclear Magnetic Resonance Imaging8MUJSystem, Planning, Radiation Therapy Treatment6KPSSystem, Tomography, Computed, Emission5All 110 devices
- LiverSmartResonance Health Analysis Services Pty Ltd · Radiology
- BoneMRIMRIguidance B.V · Radiology
- qXR-BTQure.ai Technologies · Radiology
- BU-CADTaiHao Medical Inc. · Radiology
- EchoGo Core (2.0)Ultromics Limited · Radiology
- VBrainVysioneer Inc. · Radiology
- Koios DSKoios Medical, Inc. · Radiology
- RT-Mind-AIMedMind Technology Co., Ltd. · Radiology
- HealthPPTZebra Medical Vision Ltd. · Radiology
- LVivo SeamlessDiA Imaging Analysis Ltd · Radiology
- Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · Radiology
- Cydar EV (Series B) and Cydar EV MapsCydar Ltd. · Radiology
- Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- MammoScreen 2.0Therapixel · Radiology
- OnQ NeuroCorTechs Labs, Inc · Radiology
- Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemHyperfine, Inc. · Radiology
- Soteria.AIOmega Medical Imaging, LLC · Radiology
- Lunit INSIGHT MMGLunit Inc. · Radiology
- TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co.,LTD · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- Lunit INSIGHT CXR TriageLunit Inc. · Radiology
- Critical Care Suite with Endotracheal Tube Positing AI algorithmGE Medical Systems, LLC · Radiology
- Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB · Radiology
- FlightPlan for LiverGE Medical Systems SCS · Radiology
- Contour ProtegeAIMIM Software Inc. · Radiology
- SwiftMRAIRS Medical Inc. · Radiology
- StrokeSENS LVOCircle Neurovascular Imaging, Inc · Radiology
- VBrain-OARVysioneer Inc. · Radiology
- SubtlePETSubtle Medical, Inc. · Radiology
- Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems · Radiology
- Deep Learning Image ReconstructionGE Healthcare Japan Corporation · Radiology
- Intelligent NRCanon Inc. · Radiology
- HealthCCSngZebra Medical Vision Ltd. · Radiology
- ClariSIGMAMClariPi Inc. · Radiology
- Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Aquilion Exceed LBCanon Medical Systems Corporation · Radiology
- HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- AmCAD-UTAmCad BioMed Corporation · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems · Radiology
- RayStation 11.0RaySearch Laboratories AB (publ) · Radiology
- AI SegmentationVarian Medical Systems, Inc. · Radiology
- Auto Lung Nodule DetectionSamsung Electronics Co.,Ltd. · Radiology
- EndoNautTherenva SAS · Radiology
- RBkneeRadiobotics ApS · Radiology
- Discovery MI Gen2GE Medical Systems, LLC. · Radiology
- TruSPECT Radiological Image Processing StationSpectrum Dynamics Medical Ltd · Radiology
- InferRead CT Stroke.AIInfervision Medical Technology Co., Ltd. · Radiology
- uCT ATLAS with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · Radiology
- Vereos PET/CTPhilips Medical Systems Nederland B.V. · Radiology
- KosmosEchoNous, Inc. · Radiology
- breastscape v1.0Olea Medical · Radiology
- qER-QuantQure.ai Technologies · Radiology
- syngo.via RT Image SuiteSiemens Medical Solutions USA Inc. · Radiology
- aPROMISEEXINI Diagnostics AB · Radiology
- ClariCT.AIClariPi Inc. · Radiology
- Volpara Imaging SoftwareVolpara Health Technologies Limited · Radiology
- Us2.v1eko.ai Pte. Ltd. d/b/a Us2.ai · Radiology
- Chest-CADImagen Technologies, Inc · Radiology
- Change Healthcare Anatomical AIChange Healthcare Canada Company · Radiology
- PowerLook Density Assessment V4.0iCAD, Inc. · Radiology
- HALONico.Lab B.V. · Radiology
- MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc. · Radiology
- RayStation 10.1RaySearch Laboratories AB (publ) · Radiology
- Precise PositionPhilips Healthcare (Suzhou) Co., Ltd. · Radiology
- Qmenta Care Platform FamilyMint Labs, Inc., d/b/a. QMENTA · Radiology
- syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc. · Radiology
- OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical · Radiology
- Transpara 1.7.0ScreenPoint Medical B.V. · Radiology
- CINA CHESTAvicenna.AI · Radiology
- Overjet Dental AssistOverjet, Inc. · Radiology
- SIGNA 7.0TGE Medical Systems, LLC · Radiology
- HS40 Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- HYPER AiRShanghai United Imaging Healthcare Co.,Ltd. · Radiology
- Cartesion Prime (PCD-1000A/3) V10.8Canon Medical Systems Corporation · Radiology
- MEDO-ThyroidMEDO DX Pte. Ltd. · Radiology
- Preview ShoulderGenesis Software Innovations · Radiology
- Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC · Radiology
- AI SegmentationVarian Medical Systems, Inc. · Radiology
- Saige-QDeepHealth, Inc. · Radiology
- BriefCase, RIB Fractures Triage (RibFx)Aidoc Medical, Ltd. · Radiology
- DV. TargetDeepvoxel INC · Radiology
- Eclipse II with Smart Noise CancellationCarestream Health, Inc. · Radiology
- SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · Radiology
- syngo.CT Lung CADSiemens Healthcare GmbH · Radiology
- MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc. · Radiology
- Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation · Radiology
- Viz ICHViz.ai, Inc. · Radiology
- VBrainVysioneer Inc. · Radiology
- OncospaceOncospace, Inc. · Radiology
- ProFound AI Software V3.0iCAD Inc. · Radiology
- Imbio RV/LV SoftwareImbio, LLC · Radiology
- Optellum Virtual Nodule Clinic, Optellum software, Optellum platformOptellum Ltd · Radiology
- Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- MaxFOV 2GE Medical Systems, LLC. · Radiology
- SubtleMRSubtle Medical, Inc. · Radiology
- NinesMeasureNines, Inc. · Radiology
- OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging AI, Inc. · Radiology
- TruPlanCircle Cardiovascular Imaging Inc. · Radiology
- Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation · Radiology
- LVivo Software ApplicationDiA Imaging Analysis Ltd · Radiology
- QUIBIM Precision Prostate (qp-Prostate)QUIBIM S.L. · Radiology
- Visage Breast DensityVisage Imaging GmbH · Radiology
- Vantage Orian 1.5T, MRT-1550, V6.0Canon Medical Systems Corporation · Radiology
- uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd. · Radiology
- ART-PlanTheraPanacea · Radiology
- Hepatica v1 (Hepatica v1.0.0)Perspectum Ltd. · Radiology
- Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-iCanon Medical Systems Corporation · Radiology
- Imagio Breast Imaging SystemSeno Medical Instruments, Inc. · Radiology
- BrainInsightHyperfine Research, Inc · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2021?
110 AI-enabled radiology devices have a final decision dated 2021, from 83 companies.
How does 2021 compare with 2020 for AI radiology devices?
2021 has 110 radiology AI devices, 11.1% more than 2020 (99).
Which companies cleared the most AI radiology devices in 2021?
Canon Medical Systems Corporation (7), Siemens Medical Solutions USA, Inc. (5), Ge Medical Systems, LLC (4).
What was the most recent AI radiology device in 2021?
LiverSmart from Resonance Health Analysis Services Pty Ltd (K213776), decided on December 29, 2021. Product code PCS.
Which product codes were most common for AI radiology devices in 2021?
QIH (Automated Radiological Image Processing Software): 19; LLZ (System, Image Processing, Radiological): 16; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 9.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2021,” https://ai-device-radar.vercel.app/specialty/radiology/2021 (FDA list through 2026-06-29).