FDA product code QRI: Surgical Planning Software For Neurological Stereotaxic Instruments
QRI is the FDA product code for surgical planning software for neurological stereotaxic instruments. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under QRI, 1 in the last five years. The average 510(k) review took 140 days (median 140).
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.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Planning Software For Neurological Stereotaxic Instruments |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QRI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 140 |
Top QRI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| FHC, Inc. | 1 | 2023-09-08 |
Most recent QRI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231141 | FHC, Inc. | STarFix Designer Software C0265 | 2023-09-08 | 140 |
Recalls for QRI devices
openFDA lists no recalls for product code QRI.
Frequently asked questions
What is FDA product code QRI?
QRI is the FDA product code for surgical planning software for neurological stereotaxic instruments. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the Neurology panel.
What device class is QRI?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code QRI?
Across 1 cleared submissions the average was 140 days from receipt to decision (median 140).
Which companies have the most QRI clearances?
FHC, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QRI
- Run a recall and safety report across every QRI manufacturer
- Watch product code QRI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.