510(k) Report

FDA applicant

Cerebral Assessment Systems, Inc.

Pittsford, NY1 decision2015–20150 recalls

FDA records 1 decision for Cerebral Assessment Systems, Inc. (Pittsford, NY) in 2015: 1 De Novo grant. All are in product code PKQ (Computerized Cognitive Assessment Aid). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Cerebral Assessment Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Cerebral Assessment Systems, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cerebral Assessment Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • PKQComputerized Cognitive Assessment Aid1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN130033CognivueCerebral Assessment Systems, Inc. · 20151cites it

What has FDA decided for it lately?

  • DEN130033CognivueCerebral Assessment Systems, Inc. · 2015

The one decision as Cerebral Assessment Systems, Inc. →