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510(k) K162862

Raycast High Precision Lung Board Solution by Orfit Industries NV — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2016
Date Received
October 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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