OSCAR (OSCAR Prime, OSCAR Classic)
FDA 510(k) K181943 · Genoray Co., Ltd.
510(k) numberK181943
Submission
- Device name
- OSCAR (OSCAR Prime, OSCAR Classic)
- Applicant
- Genoray Co., Ltd.
Seongnam-Si, KR - Received
- July 20, 2018
- Decision date
- August 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was OSCAR (OSCAR Prime, OSCAR Classic) cleared by the FDA?
OSCAR (OSCAR Prime, OSCAR Classic) (K181943) received a 510(k) decision of Substantially Equivalent on August 17, 2018, 28 days after the submission was received.
What is the product code of K181943?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.