CTC Workstation, Model 2200

FDA 510(k) K062229 · Medical Diagnostic Technologies, Inc.

Substantially Equivalent

510(k) numberK062229

Submission

Device name
CTC Workstation, Model 2200
Applicant
Medical Diagnostic Technologies, Inc.
Las Vegas, NV, US
Received
August 2, 2006
Decision date
September 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was CTC Workstation, Model 2200 cleared by the FDA?

CTC Workstation, Model 2200 (K062229) received a 510(k) decision of Substantially Equivalent on September 11, 2006, 40 days after the submission was received.

What is the product code of K062229?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.