Beamscan MR
FDA 510(k) K191646 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten
510(k) numberK191646
Submission
- Device name
- Beamscan MR
- Applicant
- Ptw-Freiburg Physikalisch-Technische-Werkstaetten
Freiburg, DE - Received
- June 20, 2019
- Decision date
- February 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Beamscan MR cleared by the FDA?
Beamscan MR (K191646) received a 510(k) decision of Substantially Equivalent on February 21, 2020, 246 days after the submission was received.
What is the product code of K191646?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.