FDA Clears Syngo Carbon Space (VA4) PACS from Siemens Healthineers

The U.S. FDA has granted 510(k) clearance to Siemens Healthineers' Syngo Carbon Space (VA4) picture archiving and communication system (PACS) software.

• The system is classified as a picture archiving and communication system (PACS) under FDA product code LLZ.
• The 510(k) clearance pathway indicates the device is substantially equivalent to a legally marketed predicate.

Automated summary

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