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510(k) K230787

Oscar 15 & Oscar 15i by Genoray Co., Ltd. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2023
Date Received
March 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

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  • K181943 — OSCAR (OSCAR Prime, OSCAR Classic) (August 17, 2018)
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