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FDA 510(k)

Microscope Navigation Software

K-Number: K172820 · 2018-03-01

ApplicantBrainlab AG
Decision Date2018-03-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Microscope Navigation Software is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2018-03-01 under approval number K172820. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microscope Navigation Software?

Microscope Navigation Software is a medical device that received FDA 510(k) clearance on 2018-03-01. It is manufactured by Brainlab AG. The 510(k) number is K172820.

When was Microscope Navigation Software approved by the FDA?

Microscope Navigation Software received FDA 510(k) clearance on 2018-03-01, under approval number K172820.

What company makes Microscope Navigation Software?

Microscope Navigation Software is manufactured by Brainlab AG.

What is the FDA product code for Microscope Navigation Software?

The FDA product code for Microscope Navigation Software is HAW.

Related Clinical Trials

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Other Devices by Brainlab AG

K153653DICOM Viewer K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review K190250Microscope Navigation K183605Spine & Trauma Navigation K191285Spine & Trauma Navigation

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Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

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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