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FDA 510(k)

Brainlab Elements Guide XT, Guide 3.0

K-Number: K213930 · 2022-04-19

ApplicantBrainlab AG
Decision Date2022-04-19
Product CodeQQC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Brainlab Elements Guide XT, Guide 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K213930. The device is classified under product code QQC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brainlab Elements Guide XT, Guide 3.0?

Brainlab Elements Guide XT, Guide 3.0 is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Brainlab AG. The 510(k) number is K213930.

When did Brainlab Elements Guide XT, Guide 3.0 receive FDA 510(k) clearance?

Brainlab Elements Guide XT, Guide 3.0 received FDA 510(k) clearance on 2022-04-19, under 510(k) number K213930.

Who is the listed applicant for Brainlab Elements Guide XT, Guide 3.0?

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

What is the FDA product code for Brainlab Elements Guide XT, Guide 3.0?

The FDA product code for Brainlab Elements Guide XT, Guide 3.0 is QQC.

Related Clinical Trials

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NCT05891002Accuracy of Robotically Assisted Cranial BiopsiesTERMINATED

Other records listing Brainlab AG 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.

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutK252562Spine & Trauma Navigation InstrumentsK243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADK243142Cranial 4Pi ImmobilizationK250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RTK243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

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Related Devices (Code: QQC)

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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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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