WebThe predicate device for this submission is the Ion™ Endoluminal System (K182188), cleared on February 14, 2024. 4. Device Description . The Ion™ Endoluminal System (Model IF1000) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in WebIntuitive Surgical, Inc. Jyoti Singh Sr. Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086 Re: K202470 Trade/Device Name: Ion Endoluminal System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 18, 2024 …
Ion lung biopsy system from Intuitive Surgical wins FDA approval
WebDec 12, 2024 · The Ion endoluminal system is Intuitive's robotic-assisted platform for minimally invasive biopsy in the lung. We built Ion on the belief that collecting lung tissue … Procedures using the Ion Endoluminal System may be associated with longer … During the bronchoscopy, use Ion’s controller to navigate to the target along … Procedures using the Ion Endoluminal System may be associated with longer … Ion endoluminal system. The Ion Endoluminal System (Model IF1000) … Ion balances flexibility with stability in the hard-to-reach periphery. 2 The thin fiber … Important safety information. Patients should talk to their doctor to decide if … Oliver Keown, MD Managing Director, Intuitive Ventures. Oliver is managing … Intuitive helps build technology proficiency through five training pathways that are … Web3 min read. Intuitive has today announced the release of preliminary data from 69 subjects participating in the Prospective, Multi-Center Evaluation of the Clinical Utility (PRECIsE) … cfmoto snow tracks
Intuitive Surgical
WebINTUITIVE SURGICAL, INC ION SYSTEM CART: Back to Search Results: Model Number 380748-60: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problem Pneumothorax (2012) Event Date 02/09/2024: Event Type Injury Manufacturer Narrative ... WebOct 18, 2024 · PRECIsE is the first multi-center study of the Ion system’s shape-sensing, robotic-assisted technology. Among the initial results of the ongoing study reported … cf moto snyper 800 accessories