Radiology · 2016

FDA-cleared AI devices for radiology 2016

2016 has 11 radiology AI devices, 1000% more than 2015 (1). That is 0.9% of the 1,230 radiology devices on the FDA list, and 61.1% of all AI-device decisions dated 2016. The most active were ALGOMEDICA (1), Clarius Mobile Health Corp. (1), ClearView Diagnostics Inc. (1). The newest is ClearView cCAD from ClearView Diagnostics Inc., decided on December 28, 2016.

112016 devices

11Companies

61.1%Of all 2016 AI devices

0.9%Of all radiology

Companies in 2016

By month

JanFebMarAprMayJunJulAugSepOctNovDec

Radiology AI devices by month in 2016: Jan 1, Feb 0, Mar 0, Apr 0, May 0, Jun 1, Jul 2, Aug 1, Sep 2, Oct 0, Nov 2, Dec 2

Product codes

LLZSystem, Image Processing, Radiological7 IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1 MYNAnalyzer, Medical Image1 OEBLung Computed Tomography System, Computer-Aided Detection1 OWBInterventional Fluoroscopic X-Ray System1

All 11 devices

All radiology devices All AI clearances in 2016 Top radiology AI devices 201716 2026 radiology

Frequently asked questions

How many FDA-cleared AI radiology devices were there in 2016?

11 AI-enabled radiology devices have a final decision dated 2016, from 11 companies.

How does 2016 compare with 2015 for AI radiology devices?

2016 has 11 radiology AI devices, 1000% more than 2015 (1).

Which companies cleared the most AI radiology devices in 2016?

ALGOMEDICA (1), Clarius Mobile Health Corp. (1), ClearView Diagnostics Inc. (1).

What was the most recent AI radiology device in 2016?

ClearView cCAD from ClearView Diagnostics Inc. (K161959), decided on December 28, 2016. Product code LLZ.

Which product codes were most common for AI radiology devices in 2016?

LLZ (System, Image Processing, Radiological): 7; IYN (System, Imaging, Pulsed Doppler, Ultrasonic): 1; MYN (Analyzer, Medical Image): 1.

Cite as: AI Device Radar, “FDA-cleared AI devices for radiology 2016,” https://ai-device-radar.vercel.app/specialty/radiology/2016 (FDA list through 2026-06-29).