510(k) · Radiology

EchoPAC Software Only, EchoPAC Plug-in

by GE Medical Systems Ultrasound and Primary Care Diagnostics,

EchoPAC Software Only, EchoPAC Plug-in is an AI-enabled medical device from GE Medical Systems Ultrasound and Primary Care Diagnostics, that the U.S. FDA cleared through 510(k) K220940 on July 22, 2022. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.

Key facts

Submission numberK220940
Pathway510(k)
Date of final decision
Company (FDA list)GE Medical Systems Ultrasound and Primary Care Diagnostics,
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)GE Medical Systems Ultrasound and Primary Care Diagnostics
Applicant locationWauwatosa, WI, US
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EchoPAC Software Only, EchoPAC Plug-in went through this pathway (K220940).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #43 of 305 under that code. GE Medical Systems Ultrasound and Primary Care Diagnostics, has 31 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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