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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

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.

1 linked reportMalfunction 1
01112024-10: 1 reports for this device10
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-101—
This device (reports/month)Average device in DIF, DKB (reports/device/month)
Recall history

No recalls linked.

Regulatory clearances

    Predicate lineage

    K993755

    Cited as predicate by: K150606

    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
    2026-02-26NAINo action indicatedSiemens Healthcare Diagnostics Products Ltd.0
    2024-05-24NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2024-05-24NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2022-03-30NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2022-03-30NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2022-03-08VAIVoluntary action indicatedSiemens Healthcare Diagnostics, Inc.2
    2022-03-08VAIVoluntary action indicatedSiemens Healthcare Diagnostics, Inc.2
    2021-08-19NAINo action indicatedSiemens Healthcare Diagnostics Inc0
    2021-08-19NAINo action indicatedSiemens Healthcare Diagnostics Inc0
    2021-03-12NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2021-03-12NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2019-03-18NAINo action indicatedSiemens Healthcare Diagnostics Inc.0
    2018-05-24NAINo action indicatedSiemens Healthcare Diagnostics Manufacturing Limited0
    2018-03-02VAIVoluntary action indicatedSiemens Healthcare Diagnostics, Inc.4
    2018-03-02VAIVoluntary action indicatedSiemens Healthcare Diagnostics, Inc.4
    2017-11-29NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2017-11-29NAINo action indicatedSiemens Healthcare Diagnostics, Inc.0
    2017-11-09NAINo action indicatedSiemens Healthcare Diagnostics Inc0
    2017-09-26NAINo action indicatedSiemens Healthcare Diagnostics Inc.0
    2017-08-25NAINo action indicatedSiemens Healthcare Diagnostics Inc.0
    2012-06-29WLWarning LetterSiemens Healthcare Diagnostics, Inc.—
    2012-06-29WLWarning LetterSiemens Healthcare Diagnostics, Inc.—
    2012-05-29WLWarning LetterSiemens Healthcare Diagnostics, Inc.—
    2012-05-29WLWarning LetterSiemens Healthcare Diagnostics, Inc.—
    2012-05-10WLWarning LetterSiemens Healthcare Diagnostics, Inc.—
    2012-05-10WLWarning LetterSiemens Healthcare Diagnostics, Inc.—
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