510(k) · Radiology

SubtlePET

by Subtle Medical, Inc.

SubtlePET is an AI-enabled medical device from Subtle Medical, Inc. that the U.S. FDA cleared through 510(k) K211964 on September 28, 2021. 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 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK211964
Pathway510(k)
Date of final decision
Company (FDA list)Subtle Medical, Inc.
Lead review panelRadiology
Primary product codeKPS — System, Tomography, Computed, Emission
Applicant (openFDA)Subtle Medical, Inc.
Applicant locationMenlo Park, CA, US
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. SubtlePET went through this pathway (K211964).

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 #9 of 26 under that code. Subtle Medical, Inc. has 10 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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