DeviceClearance

Product code QWT— Neurology

BrainSee

Classification name
Prognostic Assessment Software Of Mild Cognitive Impairment
Device class
Class 2
Regulation
21 CFR 882.1454
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Prognostic assessment software of mild cognitive impairment. Prognostic assessment software of mild cognitive impairment is a prescription-only device that combines information from multiple clinical data sources to produce an output indicative of the likelihood that a patient diagnosed with mild cognitive impairment will progress to more severe forms of cognitive impairment, or will develop dementia, such as Alzheimer’s disease dementia, within a specified period of time. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic too.”

— U.S. Food and Drug Administration, device classification record for product code QWT under 21 CFR 882.1454, via openFDA

Market context for product code QWT

FDA has cleared 1 device under product code QWT, all in 2024, 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 QWT

Recent clearances under product code QWT

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