SonoSync
FDA 510(k) K241302 · Samsung Medison Co., Ltd.
510(k) numberK241302
Submission
- Device name
- SonoSync
- Applicant
- Samsung Medison Co., Ltd.
Hongcheon-Gun, KR - Received
- May 9, 2024
- Decision date
- August 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SonoSync cleared by the FDA?
SonoSync (K241302) received a 510(k) decision of Substantially Equivalent on August 23, 2024, 106 days after the submission was received.
What is the product code of K241302?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.