ClearON Mobile
FDA 510(k) K183478 · Rayence Co., Ltd.
510(k) numberK183478
Submission
- Device name
- ClearON Mobile
- Applicant
- Rayence Co., Ltd.
Hwaseong-Si, KR - Received
- December 17, 2018
- Decision date
- March 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was ClearON Mobile cleared by the FDA?
ClearON Mobile (K183478) received a 510(k) decision of Substantially Equivalent on March 1, 2019, 74 days after the submission was received.
What is the product code of K183478?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.