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510(k) K202394

EOSedge by Eos Imaging — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2020
Date Received
August 21, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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  • K231917 — VEA Align (January 5, 2024)
  • K232086 — spineEOS (October 24, 2023)
  • K192079 — EOSedge (November 27, 2019)
  • K172346 — sterEOS Workstation (June 19, 2018)
  • K160914 — sterEOS Workstation (April 22, 2016)
  • K152788 — EOS System (October 21, 2015)

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