QRI — Surgical Planning Software For Neurological Stereotaxic Instruments Class II

FDA Device Classification

Classification Details

Product Code
QRI
Device Class
Class II
Regulation Number
882.4560
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K231141fhcSTarFix Designer Software C0265September 8, 2023