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510(k) Data Aggregation
K Number
K033340Device Name
LEKSELL SURGIPLAN WITH IMAGEMERGEManufacturer
Date Cleared
2004-02-12
(118 days)
Product Code
Regulation Number
882.4560Type
SpecialPanel
NeurologyReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Leksell SurgiPlan® with ImageMerge™ accessory is a computer system intended for use in planning invasive intra-cranial stereotactic surgical procedures
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter for the Leksell Elekta SurgiPlan, a stereotaxic instrument. It does not contain information on device acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to a legally marketed predicate device, but it doesn't detail performance studies or specific acceptance metrics.
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