510(k) · Radiology

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

by Canon Medical Systems Corporation

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is an AI-enabled medical device from Canon Medical Systems Corporation that the U.S. FDA cleared through 510(k) K232526 on September 12, 2023. Its lead review panel is Radiology and its primary product code is JAA (System, X-Ray, Fluoroscopic, Image-Intensified).

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

Key facts

Submission numberK232526
Pathway510(k)
Date of final decision
Company (FDA list)Canon Medical Systems Corporation
Lead review panelRadiology
Primary product codeJAA — System, X-Ray, Fluoroscopic, Image-Intensified
Applicant (openFDA)Canon Medical Systems Corporation
Applicant locationOtawara-Shi, JP
Device classClass 2
Regulation number21 CFR 892.1650
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. XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 went through this pathway (K232526).

openFDA lists it as a Class 2 device under 21 CFR 892.1650. Class II devices are moderate risk and are subject to general and special controls.

Product code JAA covers 4 devices on the FDA AI list. By decision date, this device is #3 of 4 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.

Similar devices (product code JAA)

More from Canon Medical Systems Corporation