RADspeed Pro
K-Number: K233722 · 2024-02-23
ApplicantShimadzu Corporation
Decision Date2024-02-23
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RADspeed Pro is a medical device manufactured by Shimadzu Corporation. It received FDA 510(k) clearance on 2024-02-23 under approval number K233722. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RADspeed Pro?
RADspeed Pro is a medical device that received FDA 510(k) clearance on 2024-02-23. It is manufactured by Shimadzu Corporation. The 510(k) number is K233722.
When was RADspeed Pro approved by the FDA?
RADspeed Pro received FDA 510(k) clearance on 2024-02-23, under approval number K233722.
What company makes RADspeed Pro?
RADspeed Pro is manufactured by Shimadzu Corporation.
What is the FDA product code for RADspeed Pro?
The FDA product code for RADspeed Pro is KPR.
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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.