Cleared Traditional

DORO LUCENT? iXI and iMRI Headrest System

K191740 · Pro-Med Instruments GmbH · Neurology
Feb 2020
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K191740 is an FDA 510(k) clearance for the DORO LUCENT? iXI and iMRI Headrest System, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Pro-Med Instruments GmbH (Freiburg, DE). The FDA issued a Cleared decision on February 21, 2020, 235 days after receiving the submission on July 1, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K191740 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2019
Decision Date February 21, 2020
Days to Decision 235 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBL — Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4460

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