Folliscan— 510(k) K252332

Substantially Equivalent

Mim Fertility

FDA 510(k) clearance K252332 for Folliscan, Substantially Equivalent on 2026-04-20. Applicant: Mim Fertility. Device class: 2.

Clearance details

Applicant: Mim Fertility
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-07-25
Decision date: 2026-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warszawa, PL

Download summary PDF View on FDA.gov ↗

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