510(k) Report

FDA applicant

Navigant Consulting - on Behalf of Esaote S.P.A.

Indianapolis, IN1 decision2019–20190 recalls

FDA records 1 decision for Navigant Consulting - on Behalf of Esaote S.P.A. (Indianapolis, IN) in 2019: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). 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 Navigant Consulting - on Behalf of Esaote S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Navigant Consulting - on Behalf of Esaote S.P.A. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Navigant”

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