510(k) Report

FDA applicant

Cardiovascular Imaging Technologies

Lee'S Summit, MO7 decisions2004–20200 recalls

FDA records 7 decisions for Cardiovascular Imaging Technologies (Lee'S Summit, MO) from 2004 to 2020: 7 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 65 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Cardiovascular Imaging Technologies, LLC”.

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 Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2008: 12012: 12016: 12018: 12020: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission6decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 65 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K080770Imagenmd with ImagenqCardiovascular Imaging Technologies, LLC · 20083cite it
  • K050366ImagenproCardiovascular Imaging Technologies, LLC · 20051cites it
  • K152503ImagenSPECTCardiovascular Imaging Technologies · 20161cites it

What has FDA decided for it lately?

  • K201933ImagenSPECT 3.0Cardiovascular Imaging Technologies · 2020
  • K173547ImagenUniversalCardiovascular Imaging Technologies · 2018
  • K152503ImagenSPECTCardiovascular Imaging Technologies · 2016
  • K122241IMAGEN3DCardiovascular Imaging Technologies · 2012
  • K080770Imagenmd with ImagenqCardiovascular Imaging Technologies, LLC · 2008
  • K050366ImagenproCardiovascular Imaging Technologies, LLC · 2005
  • K041671ImagenmdCardiovascular Imaging Technologies, LLC · 2004

All 4 as Cardiovascular Imaging Technologies →All 3 as Cardiovascular Imaging Technologies, LLC →

Other applicant names beginning “Cardiovascular”

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

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