Cleared Traditional

visor2 system

K210109 · Eemagine Medical Imaging Solutions GmbH · Neurology
Apr 2022
Decision
444d
Days
Class 2
Risk

About This 510(k) Submission

K210109 is an FDA 510(k) clearance for the visor2 system, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Eemagine Medical Imaging Solutions GmbH (Berlin, DE). The FDA issued a Cleared decision on April 8, 2022, 444 days after receiving the submission on January 19, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K210109 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2021
Decision Date April 08, 2022
Days to Decision 444 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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