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510(k) K152788

EOS System by Eos Imaging — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2015
Date Received
September 25, 2015
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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  • K232086 — spineEOS (October 24, 2023)
  • K202394 — EOSedge (September 16, 2020)
  • K192079 — EOSedge (November 27, 2019)
  • K172346 — sterEOS Workstation (June 19, 2018)
  • K160914 — sterEOS Workstation (April 22, 2016)

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