510(k) · Radiology

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

by Canon Medical Systems Corporation

Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is an AI-enabled medical device from Canon Medical Systems Corporation that the U.S. FDA cleared through 510(k) K222819 on March 3, 2023. Its lead review panel is Radiology and its primary product code is JAK (System, X-Ray, Tomography, Computed).

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

Key facts

Submission numberK222819
Pathway510(k)
Date of final decision
Company (FDA list)Canon Medical Systems Corporation
Lead review panelRadiology
Primary product codeJAK — System, X-Ray, Tomography, Computed
Applicant (openFDA)Canon Medical Systems Corporation
Applicant locationOtawara-Shi, JP
Device classClass 2
Regulation number21 CFR 892.1750
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. Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i went through this pathway (K222819).

openFDA lists it as a Class 2 device under 21 CFR 892.1750. Class II devices are moderate risk and are subject to general and special controls.

Product code JAK covers 103 devices on the FDA AI list. By decision date, this device is #51 of 103 under that code. Canon Medical Systems Corporation has 42 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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