FDA applicant

Voxel

Laguna Hills, CA3 decisions1995–19950 recalls

FDA records 3 decisions for Voxel (Laguna Hills, CA) in 1995: 3 510(k) clearances. Most are in product codes IWZ (Film, Radiographic) and IXC (Illuminator, Radiographic-Film). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Voxel since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Voxel’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 “Voxel”

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

Voxel Ray Solutions, LLC 1

Voxel

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Voxel”