DeviceClearance

Product code QQC— Neurology

Brainlab Elements Guide XT, Guide 3.0

Classification name
Brain Stimulation Programming Planning Software.
Device class
Class 2
Regulation
21 CFR 882.5855
Advisory panel
Neurology
Total cleared
3
First cleared
Most recent

FDA classification definition

“The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.”

— U.S. Food and Drug Administration, device classification record for product code QQC under 21 CFR 882.5855, via openFDA

Market context for product code QQC

FDA has cleared 3 devices under product code QQC between 2021 and 2025, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code QQC

Recent clearances under product code QQC

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