510(k) · Radiology

SIGNA 7.0T

by GE Medical Systems, LLC

SIGNA 7.0T is an AI-enabled medical device from GE Medical Systems, LLC that the U.S. FDA cleared through 510(k) K211118 on May 13, 2021. 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 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK211118
Pathway510(k)
Date of final decision
Company (FDA list)GE Medical Systems, LLC
Lead review panelRadiology
Primary product codeLNH — System, Nuclear Magnetic Resonance Imaging
Applicant (openFDA)Ge Medical Systems, LLC
Applicant locationWaukesha, WI, US
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 7.0T went through this pathway (K211118).

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 #18 of 100 under that code. GE Medical Systems, LLC has 24 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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