Cleared Traditional

ClearPoint System

K181195 · Mri Interventions, Inc. · Neurology
Nov 2018
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K181195 is an FDA 510(k) clearance for the ClearPoint System, a Neurological Stereotaxic Instrument, Real-time Intraoperative Mri (Class II — Special Controls, product code ORR), submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on November 2, 2018, 182 days after receiving the submission on May 4, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K181195 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2018
Decision Date November 02, 2018
Days to Decision 182 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code ORR — Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560
Definition To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An Mri Suite.