Cleared Traditional

SonoSync

K241302 · Samsung Medison Co., Ltd. · Radiology
Aug 2024
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K241302 is an FDA 510(k) clearance for the SonoSync, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Samsung Medison Co., Ltd. (Hongcheon-Gun, KR). The FDA issued a Cleared decision on August 23, 2024, 106 days after receiving the submission on May 9, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K241302 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2024
Decision Date August 23, 2024
Days to Decision 106 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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