DeviceClearance

Product code QCI— Neurology

BTL-99-OC

Classification name
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device class
Class 2
Regulation
21 CFR 882.5802
Advisory panel
Neurology
Total cleared
9
First cleared
Most recent

FDA classification definition

“External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).”

— U.S. Food and Drug Administration, device classification record for product code QCI under 21 CFR 882.5802, via openFDA

Market context for product code QCI

FDA has cleared 9 devices under product code QCI between 2018 and 2025, filed by 8 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 QCI

Recent clearances under product code QCI

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