Leksell Surgiplan, Model 1006947
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080250 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Leksell Surgiplan, Model 1006947, is image-based neurosurgical planning software designed for use with the Leksell Stereotactic System. It processes medical imaging data to assist clinicians in planning invasive intracranial stereotactic surgical procedures, offering tools for trajectory planning and target visualization. This software aids in defining precise surgical plans for intracranial interventions, ensuring accurate alignment and execution of procedures.
The device is supplied as a software application and is intended for use in clinical neurosurgical settings. It is classified under product code HAW and received FDA clearance via a 510(k) submission (K080250) under the Special review pathway, with a decision date of May 13, 2008. No sterility or single-use/reusable designation is specified, and MRI safety data is not provided in the available records. The software is authorized for use in the United States under the stated regulatory clearance.
Frequently asked questions
What is the Leksell Surgiplan, Model 1006947 used for?
The Leksell Surgiplan, Model 1006947, is designed to assist clinicians in planning invasive intracranial stereotactic surgical procedures. It processes medical imaging data to create detailed surgical plans, offering tools for trajectory planning and target visualization. This ensures accurate alignment and execution of procedures, particularly for interventions requiring high precision within the brain.
How is the Leksell Surgiplan, Model 1006947 supplied?
This device is supplied as a software application. It is intended for use in clinical neurosurgical settings where medical imaging data can be processed to generate precise surgical plans. The software does not require physical packaging or sterilization, as it operates digitally on compatible systems.
Is the Leksell Surgiplan, Model 1006947 single-use or reusable?
The documentation does not specify whether the software is designated for single-use or reusable purposes. Since it is a software application, its functionality depends on the underlying hardware and system it runs on, which may influence its operational lifespan in a clinical setting.
What regulatory clearance does the Leksell Surgiplan, Model 1006947 hold?
The Leksell Surgiplan, Model 1006947, received FDA clearance via a 510(k) submission (K080250) under the Special review pathway. This clearance was granted on May 13, 2008, and it is authorized for use in the United States. The device is classified under product code HAW.
Does the Leksell Surgiplan, Model 1006947 include MRI safety data?
The available records for the Leksell Surgiplan, Model 1006947, do not provide information regarding MRI safety. Clinicians should consult additional documentation or manufacturer guidelines to ensure compatibility with MRI environments if needed.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LEKSELL SURGIPLAN, MODEL 1006947 (K080250) — FDA 510 (k) | Innolitics, Leksell Surgiplan, Model 1006947 510 (k) FDA Premarket Notification ..., PDF K080250 - Leksell Surgiplan, Model 1006947, fda.innolitics.com, PDF ELEKTA INSTRUMENT AB - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080250 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elekta Instrument AB
Sources (1)
- FDA 510(k) K080250 24 fields · synced Oct 1, 2026