Samsung Raypax Display Workstation
FDA 510(k) K992306 · Samsung Sds Co., Ltd.
510(k) numberK992306
Submission
- Device name
- Samsung Raypax Display Workstation
- Applicant
- Samsung Sds Co., Ltd.
Aubrey, TX, US - Received
- July 9, 1999
- Decision date
- September 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Samsung Raypax Display Workstation cleared by the FDA?
Samsung Raypax Display Workstation (K992306) received a 510(k) decision of Substantially Equivalent on September 22, 1999, 75 days after the submission was received.
What is the product code of K992306?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.