Cleared Traditional

K960265 - ADVANTAGE WINDOWS WITH FUNCTOOL OPTION (FDA 510(k) Clearance)

K960265 · GE Medical Systems · Radiology device

Jul 1996

Decision

167d

Days

Class 2

Risk

K960265 is an FDA 510(k) clearance for the ADVANTAGE WINDOWS WITH FUNCTOOL OPTION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on July 3, 1996, 167 days after receiving the submission on January 18, 1996.

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

Submission Details

510(k) Number	K960265 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1996
Decision Date	July 03, 1996
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF