QRI · Surgical Planning Software For Neurological Stereotaxic Instruments
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | QRI |
|---|---|
| Device Name | Surgical Planning Software For Neurological Stereotaxic Instruments |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231141 | STarFix Designer Software C0265 | FHC, Inc. | Sep 8, 2023 | SESE |
Top Applicants
- FHC, Inc. — 1 clearance
