Praezis Plus
by TATRAMED spol. s r.o. Slovakia 510(k)
510(k) K110644 Product code HAW
Overview
Praezis Plus is a Neurological Stereotaxic Instrument, a computer software system designed for planning intracranial stereotactic procedures. It assists neurosurgeons in targeting biopsies, lesion treatments, and other precision interventions within the brain. The device integrates imaging data to enhance surgical planning accuracy and reduce procedural risks. Its classification aligns with FDA’s Neurology advisory committee and Product Code HAW, reflecting its specialized role in stereotactic neurosurgery.
Praezis Plus is supplied as a software-only solution, intended for use in clinical settings by trained neurosurgeons. It operates on standard medical imaging platforms and does not require sterilization, single-use, or reusable components. The system is not MRI-compatible as it is not a physical device but rather a computational tool. Authorized under FDA 510(k) clearance (K110644), it was determined Substantially Equivalent (SESE) to predicate devices in 2012. No additional regulatory markings or sterility claims are stated in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110644 | Date24 May 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAW
- FDA applicant
- Tatramed Spol. S.R.O.
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from TATRAMED spol. s r.o.
Questions
What is the Praezis Plus used for in neurosurgery?
Praezis Plus is a computer software system designed specifically for planning intracranial stereotactic procedures. It helps neurosurgeons target areas within the brain with high precision for interventions like biopsies or lesion treatments. By integrating imaging data, it enhances surgical planning accuracy and minimizes procedural risks, making it a critical tool for complex neurosurgical cases.
How is the Praezis Plus supplied and does it require sterilization?
Praezis Plus is supplied exclusively as a software-only solution and does not include any physical components that require sterilization. Since it operates on standard medical imaging platforms, there are no reusable or single-use materials involved. The system is intended for use in clinical settings by trained neurosurgeons, ensuring compliance with software-based medical device regulations.
Is Praezis Plus compatible with MRI equipment?
No, Praezis Plus is not MRI-compatible. As a computational tool rather than a physical device, it does not interact with MRI machines or environments. Its functionality relies entirely on integration with existing medical imaging platforms, which must be compatible with the software’s requirements for accurate stereotactic planning.
What regulatory approval does Praezis Plus hold?
Praezis Plus holds FDA 510(k) clearance under the reference number K110644. The device was determined Substantially Equivalent (SESE) to predicate devices in 2012, following review by the FDA’s Neurology Advisory Committee. This classification reflects its specialized role in stereotactic neurosurgery under Product Code HAW.
Does Praezis Plus require any specific hardware or imaging platform?
Praezis Plus is designed to operate on standard medical imaging platforms commonly used in clinical settings. While it does not specify proprietary hardware requirements, compatibility depends on the imaging system’s ability to integrate with the software for accurate stereotactic planning. Users should ensure their existing imaging infrastructure meets the software’s technical specifications for optimal performance.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K110644