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FDA 510(k)

Marie

K-Number: K250970 · 2025-07-25

ApplicantLeo Cancer Care
Decision Date2025-07-25
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Marie is a medical device manufactured by Leo Cancer Care. It received FDA 510(k) clearance on 2025-07-25 under approval number K250970. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Marie?

Marie is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Leo Cancer Care. The 510(k) number is K250970.

When was Marie approved by the FDA?

Marie received FDA 510(k) clearance on 2025-07-25, under approval number K250970.

What company makes Marie?

Marie is manufactured by Leo Cancer Care.

What is the FDA product code for Marie?

The FDA product code for Marie is JAK.

Other Devices by Leo Cancer Care

K231612Eve Patient Positioner System

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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.

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