Leibinger Stereoplan Plus Sterotactic Treatment Plan Ing Software Package
510(k) K946033
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946033 | Date1 Sep 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Leibinger Stereoplan Plus Stereotactic Treatment Planning Software Package is a computer-based system designed for stereotactic radiosurgery and radiotherapy treatment planning. It assists clinicians in planning precise, non-invasive interventions for neurological conditions by enabling the calculation and visualization of radiation dose distributions in three-dimensional space, facilitating accurate targeting of lesions or tumors within the brain.
This software package is supplied as a digital product for use on compatible medical imaging and treatment planning workstations. It has received FDA 510(k) clearance under the product code HAW, indicating it is classified as substantially equivalent to a predicate device. The software is intended for single-use in planning sessions, though the underlying hardware and systems may require maintenance and recalibration as per manufacturer guidelines. No sterility or MRI safety classifications are specified for this software package.
Other devices from Leibinger GmbH
Questions
AI-generated answers, 1 Oct 2026
What is the Leibinger Stereoplan Plus Stereotactic Treatment Planning Software Package used for?
This software is designed specifically for stereotactic radiosurgery and radiotherapy treatment planning. It helps clinicians create highly accurate, non-invasive treatment plans for neurological conditions by calculating and visualizing radiation dose distributions in three-dimensional space. This ensures precise targeting of brain lesions or tumors, improving the safety and effectiveness of interventions.
How is the Leibinger Stereoplan Plus software supplied, and what are its key requirements?
The software is supplied as a digital product, intended for use on compatible medical imaging and treatment planning workstations. It does not require physical installation like hardware but must be integrated into existing systems capable of running the software. The underlying hardware and systems may need regular maintenance and recalibration to ensure optimal performance, as outlined by the manufacturer.
Is the Leibinger Stereoplan Plus software single-use or reusable?
The software itself is intended for single-use in planning sessions. This means it is designed to be used once per treatment planning cycle, though the core systems or workstations it operates on may be reused for subsequent sessions. The manufacturer’s guidelines should be followed for proper usage and system upkeep.
Does the Leibinger Stereoplan Plus software have any sterility or MRI safety classifications?
No sterility or MRI safety classifications are specified for this software package. Since it is a digital product, these classifications do not apply in the same way as they would for physical medical devices. Always verify compatibility with your facility’s imaging and treatment systems before use.
What regulatory clearance does the Leibinger Stereoplan Plus software hold?
The software has received FDA 510(k) clearance under product code HAW, indicating it is classified as substantially equivalent to a predicate device. This clearance was granted by the FDA’s Neurology (NE) advisory committee in 1995, confirming its compliance with regulatory standards for stereotactic treatment planning.