Beamscan MR
K-Number: K191646 · 2020-02-21
Decision Date2020-02-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Beamscan MR is a medical device manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten. It received FDA 510(k) clearance on 2020-02-21 under approval number K191646. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Beamscan MR?
Beamscan MR is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten. The 510(k) number is K191646.
When was Beamscan MR approved by the FDA?
Beamscan MR received FDA 510(k) clearance on 2020-02-21, under approval number K191646.
What company makes Beamscan MR?
Beamscan MR is manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten.
What is the FDA product code for Beamscan MR?
The FDA product code for Beamscan MR is IYE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.