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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

    K133972

    Cited as predicate by: K173132, K202902

    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
    2025-03-26VAIVoluntary action indicatedFUJIFILM MEDWORK GMBH1
    2023-09-22VAIVoluntary action indicatedFujifilm Corporation3
    2023-09-22VAIVoluntary action indicatedFujifilm Corporation3
    2023-03-10VAIVoluntary action indicatedFUJIFILM Healthcare Manufacturing Corp.0
    2023-01-27VAIVoluntary action indicatedFUJIFILM Healthcare Manufacturing Corporation Sano Office2
    2019-09-30OAIOfficial action indicatedFujifilm Corporation0
    2019-09-30OAIOfficial action indicatedFujifilm Corporation0
    2019-09-10OAIOfficial action indicatedFUJIFILM Healthcare Manufacturing Corporation Sano Office0
    2019-06-21VAIVoluntary action indicatedFUJIFILM Healthcare Americas Corporation2
    2018-07-13VAIVoluntary action indicatedFujifilm Corporation1
    2018-07-13VAIVoluntary action indicatedFujifilm Corporation1
    2018-03-29VAIVoluntary action indicatedFUJIFILM Healthcare Americas Corporation1
    2018-03-09WLWarning LetterFujifilm Corporation—
    2018-03-09WLWarning LetterFujifilm Corporation—
    2017-12-21VAIVoluntary action indicatedFUJIFILM Corporation Medical Systems Research & Development Center Kashiwa0
    2017-11-08NAINo action indicatedFUJIFILM Healthcare Americas Corporation0
    2016-11-10NAINo action indicatedFUJIFILM Healthcare Americas Corporation0
    2016-10-31NAINo action indicatedFUJIFILM Healthcare Americas Corporation0
    2015-04-22OAIOfficial action indicatedFUJIFILM Healthcare Manufacturing Corporation Sano Office7
    2015-02-19VAIVoluntary action indicatedFUJIFILM Healthcare Americas Corporation2
    2014-02-19NAINo action indicatedFUJIFILM Healthcare Manufacturing Corp.0
    2013-04-25NAINo action indicatedFujifilm Corporation0
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