Cleared Traditional

LMS-LIVER

K071241 · Median Technologies · Radiology

Jun 2007

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K071241 is an FDA 510(k) clearance for the LMS-LIVER, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Median Technologies (Winchester, US). The FDA issued a Cleared decision on June 8, 2007, 36 days after receiving the submission on May 3, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K071241 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2007
Decision Date	June 08, 2007
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF