FDA-cleared AI devices for radiology 2017
2017 has 16 radiology AI devices, 45.5% more than 2016 (11). That is 1.3% of the 1,230 radiology devices on the FDA list, and 59.3% of all AI-device decisions dated 2017. The most active were AmCad BioMed Corporation (1), Arterys, Inc. (1), Body Vision Medical Ltd. (1). The newest is Radiomics App v1.0 from Microsoft Corp., decided on December 27, 2017.
Companies in 2017
By month
Product codes
All 16 devices
- Radiomics App v1.0Microsoft Corp. · Radiology
- Infinitt PACS 7.0Infinitt Healthcare Co.,Ltd. · Radiology
- QuantraHOLOGIC, INC. · Radiology
- BladderScan Prime PLUS SystemVerathon Incorporated · Radiology
- Clarius Ultrasound SystemClarius Mobile Health Corp. · Radiology
- NeuroQuantCorTechs Labs, Inc · Radiology
- QuantXQuantitative Insights, Inc · Radiology
- syngo Application SoftwareSiemens Medical Solutions, USA, Inc. · Radiology
- SmartTargetSmartTarget, Ltd. · Radiology
- UNiD Spine AnalyzerMEDICREA INTERNATIONAL · Radiology
- Lung VisionBODY VISION MEDICAL LTD. · Radiology
- AmCAD-UVAmCad BioMed Corporation · Radiology
- PowerLook® Tomo Detection SoftwareiCAD Inc · Radiology
- SIS SoftwareSurgical Information Sciences, Inc. · Radiology
- Quantib Brain 1.2Quantib BV · Radiology
- Arterys Cardio DLARTERYS INC. · Radiology
Frequently asked questions
How many FDA-cleared AI radiology devices were there in 2017?
16 AI-enabled radiology devices have a final decision dated 2017, from 16 companies.
How does 2017 compare with 2016 for AI radiology devices?
2017 has 16 radiology AI devices, 45.5% more than 2016 (11).
Which companies cleared the most AI radiology devices in 2017?
AmCad BioMed Corporation (1), Arterys, Inc. (1), Body Vision Medical Ltd. (1).
What was the most recent AI radiology device in 2017?
Radiomics App v1.0 from Microsoft Corp. (K173420), decided on December 27, 2017. Product code LLZ.
Which product codes were most common for AI radiology devices in 2017?
LLZ (System, Image Processing, Radiological): 12; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 1; IYO (System, Imaging, Pulsed Echo, Ultrasonic): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2017,” https://ai-device-radar.vercel.app/specialty/radiology/2017 (FDA list through 2026-06-29).