510(k) · Radiology

DeepXray

by Alpha Intelligence Manifolds, Inc.

DeepXray is an AI-enabled medical device from Alpha Intelligence Manifolds, Inc. that the U.S. FDA cleared through 510(k) K223621 on September 8, 2023. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

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

Key facts

Submission numberK223621
Pathway510(k)
Date of final decision
Company (FDA list)Alpha Intelligence Manifolds, Inc.
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Alpha Intelligence Manifolds, Inc.
Applicant locationNew Taipei City, TW
Device classClass 2
Regulation number21 CFR 892.2050
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. DeepXray went through this pathway (K223621).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #81 of 305 under that code. Alpha Intelligence Manifolds, Inc. has 2 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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