Skip to content
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: K182951, K190809, K193334, K260087

    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
    2022-09-29NAINo action indicatedGE Medical Systems, LLC0
    2018-06-14VAIVoluntary action indicatedGE Medical Systems, LLC0
    2016-10-11NAINo action indicatedGE MEDICAL SYSTEMS, LLC0
    2014-11-10NAINo action indicatedGE Medical Systems, LLC0
    2014-02-28VAIVoluntary action indicatedGE Medical Systems, LLC1
    2013-06-17VAIVoluntary action indicatedGE Medical Systems, LLC1
    2012-10-11NAINo action indicatedGE Medical Systems, LLC0
    2012-03-02VAIVoluntary action indicatedGE Medical Systems, LLC7
    2011-01-11VAIVoluntary action indicatedGE Medical Systems, LLC3
    2010-04-26NAINo action indicatedGE Medical Systems, LLC0
    2010-01-29NAINo action indicatedGE Medical Systems, LLC0
    Similar devices
    Select up to two to place side-by-side with this device.