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FDA 510(k)

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

K-Number: K192703 · 2020-10-08

ApplicantBrainlab AG
Decision Date2020-10-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K192703. 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 Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Brainlab AG. The 510(k) number is K192703.

When did Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update receive FDA 510(k) clearance?

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update received FDA 510(k) clearance on 2020-10-08, under 510(k) number K192703.

Who is the listed applicant for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

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 Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update?

The FDA product code for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update is HAW.

Related Clinical Trials

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.

NCT05891002Accuracy of Robotically Assisted Cranial BiopsiesTERMINATEDNCT07644104Efficacy and Safety of the Visual Bronchial Blocker for Lung Isolation SurgeryNOT_YET_RECRUITINGNCT07593872XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung CancerNOT_YET_RECRUITINGNCT03542409Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of GliomasCOMPLETEDNCT05132283Urologic Lymphadenectomy in AMIGORECRUITINGNCT05513859Investigational Imaging Technique During Brain SurgerySUSPENDED

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: HAW)

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.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, 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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