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FDA 510(k)

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

K-Number: K252476 · 2025-10-16

ApplicantBrainlab AG
Decision Date2025-10-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2025-10-16 under approval number K252476. 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 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout?

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Brainlab AG. The 510(k) number is K252476.

When was Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout approved by the FDA?

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout received FDA 510(k) clearance on 2025-10-16, under approval number K252476.

What company makes Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout?

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout is manufactured by Brainlab AG.

What is the FDA product code for Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout?

The FDA product code for Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout is LLZ.

Related Clinical Trials

NCT07578454 VRehab-SMA Phase 1.2 NOT_YET_RECRUITING NCT07573748 Apple Vision Pro-Assisted Vascular Identification in Lung Surgery NOT_YET_RECRUITING NCT07384741 Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients ACTIVE_NOT_RECRUITING NCT07191288 Assessing the Acute Effects of Virtual Reality Interventions on Stress RECRUITING NCT07187245 Feasibility of the Reality PAWS Program for Children in Isolation RECRUITING

Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Brainlab AG

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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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