Cleared Traditional

K983256 - ADVANTAGE WINDOWS (AW) FUSION (FDA 510(k) Clearance)

K983256 · GE Medical Systems · Radiology device

Dec 1998

Decision

90d

Days

Class 2

Risk

K983256 is an FDA 510(k) clearance for the ADVANTAGE WINDOWS (AW) FUSION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on December 15, 1998, 90 days after receiving the submission on September 16, 1998.

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

Submission Details

510(k) Number	K983256 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 16, 1998
Decision Date	December 15, 1998
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF