# K263048: Syngo Carbon Space (VA4)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthineers AG
- Decided: Sep 29, 2026 after 29 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K913770 (1991). 185 ancestors in all.
No later device cites it as a predicate yet.
3 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230561: Syngo Carbon Space VA30A, Siemens Healthcare GmbH (2023) Summary page 6.

## Indications for use
Syngo Carbon Space is indicated for display, rendering, post-processing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine, and Cardiology.

Source page: https://510kreport.com/device/K263048
Methodology: https://510kreport.com/methodology