Cleared Traditional

K022310 - ADVANTAGE WINDOWS X-RAY/MR FUSION (FDA 510(k) Clearance)

K022310 · Ge Medical Systems, Inc. · Radiology device

Aug 2002

Decision

15d

Days

Class 2

Risk

K022310 is an FDA 510(k) clearance for the ADVANTAGE WINDOWS X-RAY/MR FUSION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 1, 2002, 15 days after receiving the submission on July 17, 2002.

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

Submission Details

510(k) Number	K022310 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 17, 2002
Decision Date	August 01, 2002
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF