Surgical Planning Software For Neurological Stereotaxic Instruments
The Surgical Planning Software for Neurological Stereotaxic Instruments is a stand-alone software device used for pre- and intra-operative planning of stereotactic and image-guided neurosurgical procedures. It aids neurosurgeons in accurately targeting specific brain structures by integrating imaging data with surgical planning tools. Classified as FDA Class 2 under regulation 882.4560, it requires 510(k) clearance and falls under the Neurology medical specialty. The device is non-implantable and not life-sustaining.
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Basic Information
- Product Code
- QRI
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
A surgical planning software for neurological stereotaxic instruments is intended as a stand-alone software device used for pre- and intra-operative planning of stereotactic or image-guided surgeries.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231141 | STarFix Designer Software C0265 | Sep 08, 2023 | Substantially Equivalent | FHC, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.