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510(k) K160914

sterEOS Workstation by Eos Imaging, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2016
Date Received
April 1, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • K192079 — EOSedge (November 27, 2019)
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  • K152788 — EOS System (October 21, 2015)

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