Brain WMH
K-Number: K251527 · 2025-09-25
Device Summary
Frequently Asked Questions
What is the Brain WMH?
Brain WMH is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Quantib B.V.. The 510(k) number is K251527.
When did Brain WMH receive FDA 510(k) clearance?
Brain WMH received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251527.
Who is the listed applicant for Brain WMH?
The FDA 510(k) record lists Quantib B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Brain WMH?
The FDA product code for Brain WMH is QIH.
Other records listing Quantib B.V. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: QIH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.