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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 the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2025-05-16 under 510(k) 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. The listed applicant is Varian Medical Systems. The 510(k) number is K250099.

When did Mobius3D (4.1) receive FDA 510(k) clearance?

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

Who is the listed applicant for Mobius3D (4.1)?

The FDA 510(k) record lists Varian Medical Systems as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Varian Medical Systems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, 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.

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