Cleared Traditional

K960613 - GE ADVANTAGE WINDOWS REVIEW WORKSTATION (FDA 510(k) Clearance)

K960613 · GE Medical Systems · Radiology device

Apr 1996

Decision

77d

Days

Class 2

Risk

K960613 is an FDA 510(k) clearance for the GE ADVANTAGE WINDOWS REVIEW WORKSTATION. 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 April 30, 1996, 77 days after receiving the submission on February 13, 1996.

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

Submission Details

510(k) Number	K960613 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 13, 1996
Decision Date	April 30, 1996
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF