Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Follicle Clarity

K-Number: K212012 · 2022-01-19

ApplicantCycle Clarity
Decision Date2022-01-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Follicle Clarity is a medical device manufactured by Cycle Clarity. It received FDA 510(k) clearance on 2022-01-19 under approval number K212012. 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 Follicle Clarity?

Follicle Clarity is a medical device that received FDA 510(k) clearance on 2022-01-19. It is manufactured by Cycle Clarity. The 510(k) number is K212012.

When was Follicle Clarity approved by the FDA?

Follicle Clarity received FDA 510(k) clearance on 2022-01-19, under approval number K212012.

What company makes Follicle Clarity?

Follicle Clarity is manufactured by Cycle Clarity.

What is the FDA product code for Follicle Clarity?

The FDA product code for Follicle Clarity 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.

↑