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510(k) K100691

OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 by Bionix Development Corp. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2010
Date Received
March 10, 2010
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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