510(k) Report

FDA applicant

Bracco Diagnostics, Inc.

Monroe Township, NE2 decisions2018–20250 recalls

FDA records 2 decisions for Bracco Diagnostics, Inc. (Monroe Township, NE) from 2018 to 2025: 2 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 2 predicates, 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 Bracco Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12025: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Bracco Diagnostics, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR)…Bracco Diagnostics, Inc. · 2025
  • K181343HeartSee Cardiac P.E.T. Processing SoftwareBracco Diagnostics, Inc. · 2018

All 2 as Bracco Diagnostics, Inc. →

Other applicant names beginning “Bracco”

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

Bracco Diagnostic, Inc. 3Bracco Injeneering 2