Proton Vision
FDA 510(k) K000922 · Varian Assoc., Inc.
510(k) numberK000922
Submission
- Device name
- Proton Vision
- Applicant
- Varian Assoc., Inc.
Palo Alto, CA, US - Received
- March 22, 2000
- Decision date
- May 24, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252109 | RayStation (2024A SP3)MUJ · Traditional | RaySearch Laboratories AB (PUBL) | 12/22/2025SE |
More from RaySearch Laboratories AB (PUBL)
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| K992753 | Cadplan Plus: 3D Treatment Planning SystemMUJ · Special | 09/03/1999SE |
| K990085 | Millennium MLC -120IYE · Special | 02/08/1999SE |
| K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…JAQ · Traditional | 10/21/1998SE |
| K955844 | Applicators for Varian Varisource Remote High Dose Rate AfterloaderJAQ · Traditional | 07/26/1996SE |
| K955774 | Varis PortalvisionIYE · Traditional | 03/15/1996SE |
| K954467 | Cadplan BTJAQ · Traditional | 03/15/1996SE |
| K943224 | Varian Multileaf CollimatorIYE · Traditional | 02/02/1996SE |
| K952913 | Applicators for Varian Varisource Remote High Soes Rate AfterloaderJAQ · Traditional | 11/22/1995SE |
Questions and answers
When was Proton Vision cleared by the FDA?
Proton Vision (K000922) received a 510(k) decision of Substantially Equivalent on May 24, 2000, 63 days after the submission was received.
What is the product code of K000922?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.