Cleared Traditional

LMS-LUNG/TRACK

K070868 · Median Technologies · Radiology

May 2007

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K070868 is an FDA 510(k) clearance for the LMS-LUNG/TRACK, 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 May 15, 2007, 47 days after receiving the submission on March 29, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K070868 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2007
Decision Date	May 15, 2007
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF