Cleared Traditional

CTC WORKSTATION, MODEL 2200

K062229 · Medical Diagnostic Technologies, Inc. · Radiology
Sep 2006
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K062229 is an FDA 510(k) clearance for the CTC WORKSTATION, MODEL 2200, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Medical Diagnostic Technologies, Inc. (Las Vegas, US). The FDA issued a Cleared decision on September 11, 2006, 40 days after receiving the submission on August 2, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K062229 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2006
Decision Date September 11, 2006
Days to Decision 40 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050