Cleared Traditional

K110573 - READY VIEW (FDA 510(k) Clearance)

K110573 · Ge Healthcare (Ge Medical Systems Scs) · Radiology device

May 2011

Decision

63d

Days

Class 2

Risk

K110573 is an FDA 510(k) clearance for the READY VIEW. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Healthcare (Ge Medical Systems Scs) (Waukesha, US). The FDA issued a Cleared decision on May 3, 2011, 63 days after receiving the submission on March 1, 2011.

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

Submission Details

510(k) Number	K110573 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 01, 2011
Decision Date	May 03, 2011
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF