510(k) · Neurology

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

by Brainlab AG

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial is an AI-enabled medical device from Brainlab AG that the U.S. FDA cleared through 510(k) K223864 on September 9, 2023. Its lead review panel is Neurology and its primary product code is HAW (Neurological Stereotaxic Instrument).

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

Key facts

Submission numberK223864
Pathway510(k)
Date of final decision
Company (FDA list)Brainlab AG
Lead review panelNeurology
Primary product codeHAW — Neurological Stereotaxic Instrument
Applicant (openFDA)Brainlab AG
Applicant locationMunich, DE
Device classClass 2
Regulation number21 CFR 882.4560
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. Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial went through this pathway (K223864).

openFDA lists it as a Class 2 device under 21 CFR 882.4560. Class II devices are moderate risk and are subject to general and special controls.

Product code HAW covers 8 devices on the FDA AI list. By decision date, this device is #4 of 8 under that code. Brainlab AG has 9 AI-enabled devices on the list, and the Neurology panel accounts for 73 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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