Varis Images, Including Ximatron Digital Imaging Option
FDA 510(k) K952313 · Varian Assoc., Inc.
510(k) numberK952313
Submission
- Device name
- Varis Images, Including Ximatron Digital Imaging Option
- Applicant
- Varian Assoc., Inc.
Palo Alto, CA, US - Received
- May 17, 1995
- Decision date
- August 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Varis Images, Including Ximatron Digital Imaging Option cleared by the FDA?
Varis Images, Including Ximatron Digital Imaging Option (K952313) received a 510(k) decision of Substantially Equivalent on August 16, 1995, 91 days after the submission was received.
What is the product code of K952313?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.