K173478

Substantially Equivalent

OnSight 3D Extremity System

Applicant: Carestream Health, Inc.
Product code: JAK
Advisory panel: Radiology
Date received: 2017-11-13
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.