CTC Workstation, Model 2200
FDA 510(k) K062229 · Medical Diagnostic Technologies, Inc.
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
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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.