BeamSite
FDA 510(k) K212606 · Doseoptics, LLC
510(k) numberK212606
Submission
- Device name
- BeamSite
- Applicant
- Doseoptics, LLC
Lebanon, NH, US - Received
- August 17, 2021
- Decision date
- September 15, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Varian Medical Systems, Inc.
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| K200940 | BeamSiteIYE · Traditional | 12/11/2020SE |
Questions and answers
When was BeamSite cleared by the FDA?
BeamSite (K212606) received a 510(k) decision of Substantially Equivalent on September 15, 2021, 29 days after the submission was received.
What is the product code of K212606?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.