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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
  • 510(k)K133240Substantially equivalent (SESE) · 2014-01-31clearance family

Predicate lineage

Cited as predicate by: K181404

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
2023-09-20NAINo action indicatedVarian Medical Systems, Inc.0
2023-09-20NAINo action indicatedVarian Medical Systems, Inc.0
2022-09-07NAINo action indicatedVarian Medical Systems, Inc.0
2017-09-01NAINo action indicatedVarian Medical Systems, Inc.0
2017-07-20VAIVoluntary action indicatedVARIAN MEDICAL SYSTEMS HAAN GMBH2
2017-01-12VAIVoluntary action indicatedVarian Medical Systems Imaging Laboratory GmbH1
2016-12-15NAINo action indicatedVarian Medical Systems, Inc.0
2016-12-15NAINo action indicatedVarian Medical Systems, Inc.0
2016-08-31NAINo action indicatedVarian Medical Systems Inc0
2016-08-10NAINo action indicatedVarian Medical Systems, Inc.0
2016-08-10NAINo action indicatedVarian Medical Systems, Inc.0
2016-01-15NAINo action indicatedVarian Medical Systems, Inc.0
2016-01-15NAINo action indicatedVarian Medical Systems, Inc.0
2015-07-10NAINo action indicatedVarian Medical Systems, Inc.0
2015-07-10NAINo action indicatedVarian Medical Systems, Inc.0
2015-05-20VAIVoluntary action indicatedVarian Medical Systems, Inc.2
2015-05-20VAIVoluntary action indicatedVarian Medical Systems, Inc.2
2014-06-06NAINo action indicatedVarian Medical Systems, Inc.0
2014-06-06NAINo action indicatedVarian Medical Systems, Inc.0
2014-06-02NAINo action indicatedVarian Medical Systems Inc0
2010-05-17WLWarning LetterVarian Medical Systems, Inc.—
2010-05-17WLWarning LetterVarian Medical Systems, Inc.—
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