FDR Visionary Suite
K-Number: K233719 · 2024-03-28
ApplicantShimadzu Corporation
Decision Date2024-03-28
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
FDR Visionary Suite is a medical device manufactured by Shimadzu Corporation. It received FDA 510(k) clearance on 2024-03-28 under approval number K233719. 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 FDR Visionary Suite?
FDR Visionary Suite is a medical device that received FDA 510(k) clearance on 2024-03-28. It is manufactured by Shimadzu Corporation. The 510(k) number is K233719.
When was FDR Visionary Suite approved by the FDA?
FDR Visionary Suite received FDA 510(k) clearance on 2024-03-28, under approval number K233719.
What company makes FDR Visionary Suite?
FDR Visionary Suite is manufactured by Shimadzu Corporation.
What is the FDA product code for FDR Visionary Suite?
The FDA product code for FDR Visionary Suite 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.