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510(k) K192079

EOSedge by Eos Imaging — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2019
Date Received
August 2, 2019
Clearance Type
Traditional
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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  • K172346 — sterEOS Workstation (June 19, 2018)
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  • K152788 — EOS System (October 21, 2015)

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