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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

    Cited as predicate by: K223735

    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
    2024-01-31VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.1
    2024-01-31VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.1
    2023-01-06VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.5
    2023-01-06VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.5
    2022-10-26VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc3
    2019-09-18NAINo action indicatedSiemens Medical Solutions USA Inc0
    2019-06-10NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2019-06-10NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2019-06-07NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2019-06-07NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2019-06-06NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2017-04-27NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2016-04-15VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.2
    2015-09-09NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2015-09-09NAINo action indicatedSiemens Medical Solutions USA, Inc.0
    2015-03-27VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.6
    2014-12-12VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.1
    2014-12-12VAIVoluntary action indicatedSiemens Medical Solutions USA, Inc.1
    2014-11-07NAINo action indicatedSiemens Medical Solutions USA, Inc0
    2014-07-25NAINo action indicatedSiemens Medical Solutions USA Inc3
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