Cleared Traditional

K033400 - SENO ADVANTAGE (FDA 510(k) Clearance)

K033400 · Ge Medical Systems W-400 · Radiology device

Dec 2003

Decision

41d

Days

Class 2

Risk

K033400 is an FDA 510(k) clearance for the SENO ADVANTAGE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems W-400 (Waukesha, US). The FDA issued a Cleared decision on December 4, 2003, 41 days after receiving the submission on October 24, 2003.

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

Submission Details

510(k) Number	K033400 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 24, 2003
Decision Date	December 04, 2003
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF