510(k) · Radiology

Precision DL

by GE Healthcare

Precision DL is an AI-enabled medical device from GE Healthcare that the U.S. FDA cleared through 510(k) K223212 on April 27, 2023. Its lead review panel is Radiology and its primary product code is KPS (System, Tomography, Computed, Emission).

See also FDA-cleared AI radiology devices in 2023, all FDA AI clearances in 2023, top radiology AI devices.

Key facts

Submission numberK223212
Pathway510(k)
Date of final decision
Company (FDA list)GE Healthcare
Lead review panelRadiology
Primary product codeKPS — System, Tomography, Computed, Emission
Applicant (openFDA)GE Healthcare
Applicant locationTirat Hacarmel, IL
Device classClass 2
Regulation number21 CFR 892.1200
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. Precision DL went through this pathway (K223212).

openFDA lists it as a Class 2 device under 21 CFR 892.1200. Class II devices are moderate risk and are subject to general and special controls.

Product code KPS covers 26 devices on the FDA AI list. By decision date, this device is #11 of 26 under that code. GE Healthcare has 8 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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