LEKSELL SURGIPLAN WITH IMAGEMERGE

• K Number: K033340
• Device Name: LEKSELL SURGIPLAN WITH IMAGEMERGE
• Manufacturer: ELEKTA INSTRUMENT AB
• Date Cleared: 2004-02-12 ( 118 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Special
• Panel: NE
• Reference & Predicate Devices: N/A

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.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).