Syngo Dynamics Version 7.0
FDA 510(k) K081018 · Siemens Medical Solutions
510(k) numberK081018
Submission
- Device name
- Syngo Dynamics Version 7.0
- Applicant
- Siemens Medical Solutions
Ann Arbor, MI, US - Received
- April 10, 2008
- Decision date
- April 25, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Syngo Dynamics Version 7.0 cleared by the FDA?
Syngo Dynamics Version 7.0 (K081018) received a 510(k) decision of Substantially Equivalent on April 25, 2008, 15 days after the submission was received.
What is the product code of K081018?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.