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510(k) K131862

3DVH by Sun Nuclear Corporation — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2013
Date Received
June 24, 2013
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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  • K141800 — PERFRACTION (September 26, 2014)
  • K131466 — MAPCHECK2, ARCCHECK (August 20, 2013)
  • K131704 — EPIDOSE (August 5, 2013)

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