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510(k) K160057

ArcCHECK-MR by Sun Nuclear Corporation — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2016
Date Received
January 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • K131862 — 3DVH (August 21, 2013)
  • K131466 — MAPCHECK2, ARCCHECK (August 20, 2013)
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