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FDA 510(k)

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface

K-Number: K254010 · 2026-01-14

ApplicantBrainlab SE
Decision Date2026-01-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab SE. It received FDA 510(k) clearance on 2026-01-14 under 510(k) number K254010. 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 ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is a medical device that received FDA 510(k) clearance on 2026-01-14. The listed applicant is Brainlab SE. The 510(k) number is K254010.

When did ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface receive FDA 510(k) clearance?

ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface received FDA 510(k) clearance on 2026-01-14, under 510(k) number K254010.

Who is the listed applicant for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

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

What is the FDA product code for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface?

The FDA product code for ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface is IYE.

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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