Cleared Traditional

K093234 - INTEGRATED REGISTRATION (FDA 510(k) Clearance)

K093234 · GE Medical Systems SCS · Radiology device

Oct 2009

Decision

15d

Days

Class 2

Risk

K093234 is an FDA 510(k) clearance for the INTEGRATED REGISTRATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by GE Medical Systems SCS (Buc Cedex, FR). The FDA issued a Cleared decision on October 30, 2009, 15 days after receiving the submission on October 15, 2009.

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

Submission Details

510(k) Number	K093234 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 2009
Decision Date	October 30, 2009
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF