GE Viewpoint
FDA 510(k) K050943 · General Electric Co.
510(k) numberK050943
Submission
- Device name
- GE Viewpoint
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- April 14, 2005
- Decision date
- May 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GE Viewpoint cleared by the FDA?
GE Viewpoint (K050943) received a 510(k) decision of Substantially Equivalent on May 23, 2005, 39 days after the submission was received.
What is the product code of K050943?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.