Brain WMH
K-Number: K251527 · 2025-09-25
ApplicantQuantib B.V.
Decision Date2025-09-25
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Brain WMH is a medical device manufactured by Quantib B.V.. It received FDA 510(k) clearance on 2025-09-25 under approval number K251527. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Brain WMH?
Brain WMH is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Quantib B.V.. The 510(k) number is K251527.
When was Brain WMH approved by the FDA?
Brain WMH received FDA 510(k) clearance on 2025-09-25, under approval number K251527.
What company makes Brain WMH?
Brain WMH is manufactured by Quantib B.V..
What is the FDA product code for Brain WMH?
The FDA product code for Brain WMH is QIH.
Related Clinical Trials
Other Devices by Quantib B.V.
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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.