FDA applicant

Cardiovascular Imaging Solutions, Ltd.

Denton, TX1 decision2008–20080 recalls

FDA records 1 decision for Cardiovascular Imaging Solutions, Ltd. (Denton, TX) in 2008: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 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 Cardiovascular Imaging Solutions, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Cardiovascular Imaging Solutions, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cardiovascular”

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

Cardiovascular Systems, Inc. 29 Cardiovascular Imaging Systems, Inc. 19 Cardiovascular Diagnostics, Inc. 13 Cardiovascular Dynamics, Inc. 11 Cardiovascular Devices, Inc. 8 Cardiovascular Diagnostic Services 8 Cardiovascular Imaging Technologies 7 Cardiovascular Research, Inc. 2 Cardiovascular Group, Inc. 1 Cardiovascular Innovations 1 Cardiovascular System, Inc. 1

Cardiovascular Imaging Solutions, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cardiovascular”