Cleared Traditional

Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

K223288 · Brainlab AG · Neurology
Jul 2023
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K223288 is an FDA 510(k) clearance for the Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on July 21, 2023, 269 days after receiving the submission on October 25, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K223288 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2022
Decision Date July 21, 2023
Days to Decision 269 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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