QRI

Surgical Planning Software For Neurological Stereotaxic Instruments

Product code: QRI
Device name: Surgical Planning Software For Neurological Stereotaxic Instruments
Device class: Class 2
21 CFR: 21 CFR 882.4560
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QRI

Classification and pathway per current FDA publications. Data from openFDA (CC0).