510(k) Report

FDA product code · Neurology

Surgical Planning Software For Neurological Stereotaxic Instruments

QRIClass II21 CFR 882.4560510(k) required1 decision since 20230 recalls

1 FDA decision since 2023. 510(k) reviews decided 2021–2025 took a median of 140 days (half between 140 and 140). No recall names this code.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of QRI at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QRI

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QRI

Too few QRI 510(k)s in any year since 2007 to give a median.

Recalls per year · QRI

No recall names QRI since 2007.

Adverse event reports per year · QRI

No MAUDE report names QRI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — QRI by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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Devices in this code with the longest line of descent behind them.

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