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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: K142431

    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
    2019-06-20NAINo action indicatedComputerized Imaging Reference Systems, Inc0
    2014-10-24NAINo action indicatedSun Nuclear Corporation0
    2014-10-24NAINo action indicatedSun Nuclear Corporation0
    2013-02-06WLWarning LetterSun Nuclear Corporation—
    2013-02-06WLWarning LetterSun Nuclear Corporation—
    2012-09-28VAIVoluntary action indicatedSun Nuclear Corporation9
    2012-06-26NAINo action indicatedSun Nuclear Corporation0
    2010-07-22VAIVoluntary action indicatedSun Nuclear Corporation3
    2010-07-22VAIVoluntary action indicatedSun Nuclear Corporation3
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