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)

Functional MR V1.0

K-Number: K221426 · 2022-07-06

ApplicantOlea Medical S.A.S.
Decision Date2022-07-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Functional MR V1.0 is a medical device manufactured by Olea Medical S.A.S.. It received FDA 510(k) clearance on 2022-07-06 under approval number K221426. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Functional MR V1.0?

Functional MR V1.0 is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Olea Medical S.A.S.. The 510(k) number is K221426.

When was Functional MR V1.0 approved by the FDA?

Functional MR V1.0 received FDA 510(k) clearance on 2022-07-06, under approval number K221426.

What company makes Functional MR V1.0?

Functional MR V1.0 is manufactured by Olea Medical S.A.S..

What is the FDA product code for Functional MR V1.0?

The FDA product code for Functional MR V1.0 is LLZ.

Other Devices by Olea Medical S.A.S.

K243680Neurovascular Insight V1.0 K243681Neuro Insight V1.0

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑