QRI — Surgical Planning Software For Neurological Stereotaxic Instruments Class II
FDA product code QRI covers "Surgical Planning Software For Neurological Stereotaxic Instruments", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QRI
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231141 | fhc | STarFix Designer Software C0265 | September 8, 2023 |