Neosoma Brain Mets— 510(k) K252922

Substantially Equivalent

Neosoma, Inc.

FDA 510(k) clearance K252922 for Neosoma Brain Mets, Substantially Equivalent on 2025-12-17. Applicant: Neosoma, Inc.. Device class: 2.

Clearance details

Applicant: Neosoma, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-09-15
Decision date: 2025-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Groton, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.