STarFix Designer Software C0265
FDA 510(k)Class II (US FDA 510(k))
by Fhc, Inc.
Identifiers
- 510(k) Number
- K231141 FDA 510(k)
- FDA Product Code
- QRI 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 STarFix Designer Software C0265 is image-based neurosurgical planning software classified as Surgical Planning Software for Neurological Stereotaxic Instruments. It is designed to assist neurosurgeons, neurologists, or clinical neurophysiologists in planning and monitoring the precise positioning of microelectrodes, stimulating electrodes, or other instruments within specific anatomical structures of the brain or nervous system.
This software is supplied as a single-user license for one surgical installation, intended for use in clinical neurosurgical settings. It is not described as single-use or reusable but requires annual reactivation for continued functionality. The device holds FDA 510(k) clearance under the classification of Class II medical devices, with no explicit mention of sterility, MRI safety, or physical size specifications in the provided data.
Frequently asked questions
What specific clinical roles is the STarFix Designer Software intended to support during neurosurgical procedures?
The STarFix Designer Software is designed to assist neurosurgeons, neurologists, and clinical neurophysiologists in planning and monitoring the precise placement of microelectrodes, stimulating electrodes, or other instruments within the brain or nervous system. Its image-based planning capabilities help ensure accurate targeting of anatomical structures during neurosurgical interventions.
How is the software licensed and what does the single-user license entail for a clinical neurosurgical setting?
The STarFix Designer Software is supplied as a single-user license for one surgical installation, meaning it is intended for use by one authorized user at a single clinical neurosurgical facility. The license requires annual reactivation to maintain functionality, ensuring continued access to updates and support.
Is the software reusable or single-use, and what does that mean for its maintenance and updates?
The software is not classified as single-use or reusable in the traditional sense of physical devices. Instead, it requires annual reactivation to remain functional, which implies periodic updates or licensing renewals to maintain compliance, performance, and access to the latest features or regulatory requirements.
What regulatory pathway was followed for FDA clearance of this software, and what does that indicate about its classification?
The STarFix Designer Software received FDA clearance through a traditional 510(k) process, classified as a Class II medical device under the category of Surgical Planning Software for Neurological Stereotaxic Instruments. This indicates it underwent a premarket submission review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring its safety and effectiveness for its intended clinical use.
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: STarFix Designer - FHC - fh-co.com, STarFix Designer Software C0265 (K231141) — FDA 510(k) | Innolitics, K231141 - STarFix Designer Software C0265 - Neurology
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231141 | Class II | Active |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA 510(k) K231141 24 fields · synced Sep 18, 2026