QRI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Surgical Planning Software For Neurological Stereotaxic Instruments
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STarFix Designer Software C0265 (K231141) | FHC, Inc. | 2023-09-08 |
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