FDA-cleared AI devices for radiology 2019
2019 has 51 radiology AI devices, 27.5% more than 2018 (40). That is 4.1% of the 1,230 radiology devices on the FDA list, and 63.8% of all AI-device decisions dated 2019. The most active were Siemens Medical Solutions USA, Inc. (5), Aidoc Medical, Ltd. (3), Ge Medical Systems, LLC (3). The newest is BriefCase from Aidoc Medical, Ltd., decided on December 20, 2019.
Companies in 2019
By month
Product codes
LLZSystem, Image Processing, Radiological21JAKSystem, X-Ray, Tomography, Computed8QASRadiological Computer-Assisted Triage And Notification Software5QFMRadiological Computer-Assisted Prioritization Software For Lesions4LNHSystem, Nuclear Magnetic Resonance Imaging3MUJSystem, Planning, Radiation Therapy Treatment3QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2QIHAutomated Radiological Image Processing Software2All 51 devices
- BriefCaseAidoc Medical, Ltd. · Radiology
- QLAB Advanced Quantification SoftwarePhilips Healthcare · Radiology
- syngo.CT CaScoringSiemens Medical Solutions USA, Inc. · Radiology
- QyScore SoftwareQynapse · Radiology
- Deep Learning Image ReconstructionGE Healthcare Japan Corporation · Radiology
- IcobrainIcometrix NV · Radiology
- NemoScanSoftware Nemotec S.L. · Radiology
- TransparaScreenpoint Medical B.V. · Radiology
- PhantomMSK TraumaOrthoGrid Systems Inc. · Radiology
- HealthCXRZebra Medical Vision, Ltd. · Radiology
- RSI-MRI+MultiModal Imaging Services Corporation (dba HealthLytix) · Radiology
- EchoGo CoreUltromics Ltd · Radiology
- MEDIP PROMEDICALIP Co., Ltd · Radiology
- Cleerly LabsCleerly Inc · Radiology
- KOALAIB Lab GmbH · Radiology
- RTHawk, HeartVista Cardiac PackageHeartVista, Inc. · Radiology
- Merge PACSMerge Healthcare Incorporated · Radiology
- Ventripoint Medical System Plus (VMS+) 3.0Ventripoint Diagnostics, Ltd. · Radiology
- ProFound AI Software V2.1iCAD Inc. · Radiology
- CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)Omega Medical Imaging, LLC · Radiology
- Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. · Radiology
- SubtleMRSubtle Medical, Inc. · Radiology
- SIS Software Version 3.6.0Surgical Information Sciences, Inc. · Radiology
- AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · Radiology
- D2P3D Systems, Inc. · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- Critical Care SuiteGE Medical Systems, LLC. · Radiology
- aBSIEXINI Diagnostics AB · Radiology
- AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · Radiology
- iNtuition-Structural Heart ModuleTeraRecon Inc. · Radiology
- DeepCTDeep01 Limited · Radiology
- RayCare 2.3RaySearch Laboratories AB (publ) · Radiology
- Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical Systems Corporation · Radiology
- Koios DS for BreastKoios Medical, Inc. · Radiology
- LiverMultiScan (LMSv3)Perspectum Diagnostics Ltd · Radiology
- RayStationRaySearch Laboratories AB (publ) · Radiology
- ClariCT.AIClariPI Inc. · Radiology
- HealthICHZebra Medical Vision Ltd. · Radiology
- Aquilion ONE (TSX-305A/6) V8.9 with AiCECanon Medical Systems Corporation · Radiology
- BriefCaseAidoc Medical, Ltd. · Radiology
- SurgicalARMEDIVIS, Inc. · Radiology
- HealthPNXZebra Medical Vision Ltd. · Radiology
- Lung Vision SystemBody Vision Medical Ltd. · Radiology
- BriefCaseAidoc Medical, Ltd. · Radiology
- Deep Learning Image ReconstructionGE Medical Systems, LLC. · Radiology
- Bone VCAR (BVCAR)GE Medical Systems SCS · Radiology
- SIS Software version 3.3.0Surgical Information Sciences, Inc. · Radiology
- cmTriageCureMetrix, Inc · Radiology
- AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc. · Radiology
- SIGNA PremierGE Medical Systems, LLC · Radiology
- MRCP+ v1.0Perspectum Diagnostics Ltd · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2019?
51 AI-enabled radiology devices have a final decision dated 2019, from 37 companies.
How does 2019 compare with 2018 for AI radiology devices?
2019 has 51 radiology AI devices, 27.5% more than 2018 (40).
Which companies cleared the most AI radiology devices in 2019?
Siemens Medical Solutions USA, Inc. (5), Aidoc Medical, Ltd. (3), Ge Medical Systems, LLC (3).
What was the most recent AI radiology device in 2019?
BriefCase from Aidoc Medical, Ltd. (K192383), decided on December 20, 2019. Product code QAS.
Which product codes were most common for AI radiology devices in 2019?
LLZ (System, Image Processing, Radiological): 21; JAK (System, X-Ray, Tomography, Computed): 8; QAS (Radiological Computer-Assisted Triage And Notification Software): 5.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2019,” https://ai-device-radar.vercel.app/specialty/radiology/2019 (FDA list through 2026-06-29).