Cleared Traditional

syngo Application Software

K241569 · Siemens Medical Solutions USA, Inc. · Radiology
Oct 2024
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K241569 is an FDA 510(k) clearance for the syngo Application Software, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on October 11, 2024, 133 days after receiving the submission on May 31, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K241569 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2024
Decision Date October 11, 2024
Days to Decision 133 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