Folliscan
K-Number: K252332 · 2026-04-20
ApplicantMim Fertility
Decision Date2026-04-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Folliscan is a medical device manufactured by Mim Fertility. It received FDA 510(k) clearance on 2026-04-20 under approval number K252332. 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 Folliscan?
Folliscan is a medical device that received FDA 510(k) clearance on 2026-04-20. It is manufactured by Mim Fertility. The 510(k) number is K252332.
When was Folliscan approved by the FDA?
Folliscan received FDA 510(k) clearance on 2026-04-20, under approval number K252332.
What company makes Folliscan?
Folliscan is manufactured by Mim Fertility.
What is the FDA product code for Folliscan?
The FDA product code for Folliscan is QIH.
Related Devices (Code: QIH)
K191647QLAB Advanced Quantification SoftwarePhilips Health Care
K191171EchoGo CoreUltromics, Ltd.
K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.
K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.
K202546LVivo SeamlessDia Imaging Analysis, Ltd.
K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.
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.