Cleared Traditional

K010336 - ADVANTAGE WINDOWS CT/PET FUSION (FDA 510(k) Clearance)

K010336 · Ge Medical Systems, Inc. · Radiology device

Feb 2001

Decision

11d

Days

Class 2

Risk

K010336 is an FDA 510(k) clearance for the ADVANTAGE WINDOWS CT/PET FUSION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 16, 2001, 11 days after receiving the submission on February 5, 2001.

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

Submission Details

510(k) Number	K010336 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 05, 2001
Decision Date	February 16, 2001
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF