Cleared Traditional

K040050 - INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 (FDA 510(k) Clearance)

K040050 · Ge Medical Systems Navigation and Visualization IN · Radiology device

Mar 2004

Decision

72d

Days

Class 2

Risk

K040050 is an FDA 510(k) clearance for the INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems Navigation and Visualization IN (Salt Lake City, US). The FDA issued a Cleared decision on March 24, 2004, 72 days after receiving the submission on January 12, 2004.

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

Submission Details

510(k) Number	K040050 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 12, 2004
Decision Date	March 24, 2004
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF