Cleared Traditional

K081512 - STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE (FDA 510(k) Clearance)

K081512 · Medtronic Navigation, Inc. · Radiology device

Jul 2008

Decision

49d

Days

Class 2

Risk

K081512 is an FDA 510(k) clearance for the STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Medtronic Navigation, Inc. (Denver, US). The FDA issued a Cleared decision on July 18, 2008, 49 days after receiving the submission on May 30, 2008.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K081512 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 30, 2008
Decision Date	July 18, 2008
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF