FDA applicant

Visionary Systems, Inc.

Tucson, AZ1 decision1991–19910 recalls

FDA records 1 decision for Visionary Systems, Inc. (Tucson, AZ) in 1991: 1 510(k) clearance. All are in product code HLQ (Keratoscope, Ac-Powered). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Visionary Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Visionary Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Visionary 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

Other applicant names beginning “Visionary”

FDA records each applicant name separately; these may or may not be the same firm.

Visionary Medical Supplies, Inc. 4 Visionary Optics, LLC 3 Visionary Technologies of Miami, Inc. 2

Visionary Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Visionary”