syngo Application Software
FDA 510(k) K241569 · Siemens Medical Solutions USA, Inc.
510(k) numberK241569
Submission
- Device name
- syngo Application Software
- Applicant
- Siemens Medical Solutions USA, Inc.
Malvern, PA, US - Received
- May 31, 2024
- Decision date
- October 11, 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 syngo Application Software cleared by the FDA?
syngo Application Software (K241569) received a 510(k) decision of Substantially Equivalent on October 11, 2024, 133 days after the submission was received.
What is the product code of K241569?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.