510(k) · Radiology

SIGNA Artist

by GE Healthcare (Tianjin) Company Limited

SIGNA Artist is an AI-enabled medical device from GE Healthcare (Tianjin) Company Limited that the U.S. FDA cleared through 510(k) K202238 on September 4, 2020. Its lead review panel is Radiology and its primary product code is LNH (System, Nuclear Magnetic Resonance Imaging).

See also FDA-cleared AI radiology devices in 2020, all FDA AI clearances in 2020, top radiology AI devices.

Key facts

Submission numberK202238
Pathway510(k)
Date of final decision
Company (FDA list)GE Healthcare (Tianjin) Company Limited
Lead review panelRadiology
Primary product codeLNH — System, Nuclear Magnetic Resonance Imaging
Applicant (openFDA)Ge Healthcare (Tianjin) Company Limited
Applicant locationTianjin, CN
Device classClass 2
Regulation number21 CFR 892.1000
Decision codeSESE
Submission typeSpecial

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. SIGNA Artist went through this pathway (K202238).

openFDA lists it as a Class 2 device under 21 CFR 892.1000. Class II devices are moderate risk and are subject to general and special controls.

Product code LNH covers 100 devices on the FDA AI list. By decision date, this device is #10 of 100 under that code. GE Healthcare (Tianjin) Company Limited has 4 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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