FDA product code QWT: Prognostic Assessment Software Of Mild Cognitive Impairment

QWT is the FDA product code for prognostic assessment software of mild cognitive impairment. It is a Class II device, regulated under 21 CFR 882.1454 and reviewed by the Neurology panel. Devices under QWT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QWT devices

openFDA lists no recalls for product code QWT.

Frequently asked questions

What is FDA product code QWT?

QWT is the FDA product code for prognostic assessment software of mild cognitive impairment. It is a Class II device, regulated under 21 CFR 882.1454 and reviewed by the Neurology panel.

What device class is QWT?

Class II, regulation 21 CFR 882.1454. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QWT
• Run a recall and safety report across every QWT manufacturer
• Watch product code QWT for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times