Folliscan— 510(k) K252332

Name: FDA 510(k) clearance K252332
Creator: U.S. Food and Drug Administration
Published: 2026-04-20

Substantially Equivalent

Mim Fertility

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

Summary

Folliscan comes from Mim Fertility and is filed under product code QIH (Automated Radiological Image Processing Software). The record doesn't describe the software beyond its name and that code name.

Class II, 21 CFR 892.2050. It came in as a Traditional 510(k), and Radiology is both the classification panel and the review panel.

Mim Fertility filed from Warszawa, Poland. Review took 269 calendar days (July 25, 2025 to April 20, 2026).

Clearance details

Applicant: Mim Fertility
Product code: Product 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 ↗

Recent devices under product code QIH

view all

K262147 — CINA-Aneurysm+2026-10-19
K261733 — Ligence Heart2026-10-07
K262134 — NeuroDR2026-10-07
K260523 — QGuideCT (1.0)2026-10-05
K260055 — syngo.CT Brain Quantification2026-09-25

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