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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

    Predicate lineage

    K071134

    Cited as predicate by: K101757, K102390, K113156, K133454, K150148

    K082098

    Cited as predicate by: K101757, K102390, K112067, K113156, K130173, K133454, K150148, K150533

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2012-07-06NAINo action indicatedFujiFilm SonoSite, Inc.0
    2010-04-02NAINo action indicatedFujiFilm SonoSite, Inc.0
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