Leksell Stereotactic System

Basic Information

• Brand Name: Leksell Stereotactic System
• Primary DI: 07340201503225
• Version / Model: 1040331
• Catalog Number: 1040331
• Company Name: Elekta Solutions AB
• Labeler DUNS: 353272181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-17
• Public Version: 1
• Public Version Date: 2025-09-25
• Public Version Status: New
• Public Device Record Key: 41d3ec75-da9a-4e14-acb8-5eda6551a301

Device Description

X-RAY INDICATOR WITH MARKERS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340201503225	GS1

Premarket Submissions

Submission Number	Supplement Number
K152558	000