syngo Virtual Cockpit (VB10A)
FDA 510(k) K232744 · Siemens Healthcare GmbH
510(k) numberK232744
Submission
- Device name
- syngo Virtual Cockpit (VB10A)
- Applicant
- Siemens Healthcare GmbH
Erlanger, DE - Received
- September 7, 2023
- Decision date
- December 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was syngo Virtual Cockpit (VB10A) cleared by the FDA?
syngo Virtual Cockpit (VB10A) (K232744) received a 510(k) decision of Substantially Equivalent on December 21, 2023, 105 days after the submission was received.
What is the product code of K232744?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.