DeviceClearance

Product code QRI— Neurology

STarFix Designer Software C0265

Classification name
Surgical Planning Software For Neurological Stereotaxic Instruments
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QRI under 21 CFR 882.4560, via openFDA

Market context for product code QRI

FDA has cleared 1 device under product code QRI, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QRI

Recent clearances under product code QRI

Data sourced from openFDA. This site is unofficial and independent of the FDA.