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
  • 510(k)K120246Substantially equivalent (SESE) · 2012-08-28clearance family
Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2022-10-20NAINo action indicatedCarestream Health, Inc.0
2022-10-20NAINo action indicatedCarestream Health, Inc.0
2022-08-23NAINo action indicatedCarestream Health, Inc.0
2022-08-23NAINo action indicatedCarestream Health, Inc.0
2020-01-27NAINo action indicatedCarestream Health, Inc.0
2020-01-27NAINo action indicatedCarestream Health, Inc.0
2019-04-09NAINo action indicatedCarestream Health, Inc.0
2019-04-09NAINo action indicatedCarestream Health, Inc.0
2018-08-15VAIVoluntary action indicatedCarestream Health, Inc.3
2018-08-15VAIVoluntary action indicatedCarestream Health, Inc.3
2018-01-16VAIVoluntary action indicatedCarestream Health, Inc., Global R&D Center (Shanghai)0
2017-11-30NAINo action indicatedCarestream Health, Inc0
2017-11-02NAINo action indicatedCarestream Health, Inc.0
2017-03-23VAIVoluntary action indicatedCarestream Health, Inc.7
2016-06-30VAIVoluntary action indicatedCarestream Health, Inc.0
2016-06-30VAIVoluntary action indicatedCarestream Health, Inc.0
2013-06-05VAIVoluntary action indicatedCarestream Health, Inc.0
2013-06-05VAIVoluntary action indicatedCarestream Health, Inc.0
2012-11-06NAINo action indicatedCarestream Health, Inc0
2012-10-19NAINo action indicatedCarestream Health, Inc0
Similar devices
Select up to two to place side-by-side with this device.