Cleared Traditional

SURGIVISION INC. CLEARPOINT SYSTEM

K111073 · Surgi-Vision, Inc. · Radiology

Jun 2011

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K111073 is an FDA 510(k) clearance for the SURGIVISION INC. CLEARPOINT SYSTEM, a Neurological Stereotaxic Instrument, Real-time Intraoperative Mri (Class II — Special Controls, product code ORR), submitted by Surgi-Vision, Inc. (Irvine, US). The FDA issued a Cleared decision on June 22, 2011, 65 days after receiving the submission on April 18, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K111073 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2011
Decision Date	June 22, 2011
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Radiology (RA)
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.