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FDA 510(k)

Mobius3D (4.1)

K-Number: K250099 · 2025-05-16

ApplicantVarian Medical Systems
Decision Date2025-05-16
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mobius3D (4.1) is a medical device manufactured by Varian Medical Systems. It received FDA 510(k) clearance on 2025-05-16 under approval number K250099. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mobius3D (4.1)?

Mobius3D (4.1) is a medical device that received FDA 510(k) clearance on 2025-05-16. It is manufactured by Varian Medical Systems. The 510(k) number is K250099.

When was Mobius3D (4.1) approved by the FDA?

Mobius3D (4.1) received FDA 510(k) clearance on 2025-05-16, under approval number K250099.

What company makes Mobius3D (4.1)?

Mobius3D (4.1) is manufactured by Varian Medical Systems.

What is the FDA product code for Mobius3D (4.1)?

The FDA product code for Mobius3D (4.1) is IYE.

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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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