FDA 510(k)

FRAMELESS RADIOSURGERY COMPONENTS

K-Number: K053500 · 2006-02-03

Decision Date2006-02-03

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FRAMELESS RADIOSURGERY COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2006-02-03 under 510(k) number K053500. 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 FRAMELESS RADIOSURGERY COMPONENTS?

FRAMELESS RADIOSURGERY COMPONENTS is a medical device that received FDA 510(k) clearance on 2006-02-03. The listed applicant is Brainlab AG. The 510(k) number is K053500.

When did FRAMELESS RADIOSURGERY COMPONENTS receive FDA 510(k) clearance?

FRAMELESS RADIOSURGERY COMPONENTS received FDA 510(k) clearance on 2006-02-03, under 510(k) number K053500.

Who is the listed applicant for FRAMELESS RADIOSURGERY COMPONENTS?

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 FRAMELESS RADIOSURGERY COMPONENTS?

The FDA product code for FRAMELESS RADIOSURGERY COMPONENTS is IYE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Brainlab AG as applicant

K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K252562Spine & Trauma Navigation Instruments K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD K243142Cranial 4Pi Immobilization K250440RT 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 RT K243633Brainlab 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)

View all 132 devices →

Related Devices (Code: IYE)

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen

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.