Medlink Diagnostic Offline Workstation
FDA 510(k) K002144 · Advanced Technology Laboratories, Inc.
510(k) numberK002144
Submission
- Device name
- Medlink Diagnostic Offline Workstation
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- July 17, 2000
- Decision date
- September 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Medlink Diagnostic Offline Workstation cleared by the FDA?
Medlink Diagnostic Offline Workstation (K002144) received a 510(k) decision of Substantially Equivalent on September 28, 2000, 73 days after the submission was received.
What is the product code of K002144?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.