FDA applicant

Galileo Cds, Inc.

Austin, TX2 decisions2025–20250 recalls

FDA records 2 decisions for Galileo Cds, Inc. (Austin, TX) in 2025: 2 510(k) clearances. All are in product code QIH (Automated Radiological Image Processing Software). Its devices cite 3 predicates, 1 of them its own earlier devices. 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 Galileo Cds, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Galileo Cds, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Galileo Cds, 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 “Galileo”

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

Galileo Electro-Optics Corp. 7

Galileo Cds, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Galileo”