# K230561: Syngo Carbon Space VA30A

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: Mar 21, 2023 after 21 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: 14 generations back to K913770 (1991). 184 ancestors in all.
4 later devices descend from it; 3 cite it directly.
3 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213665: Syngo Carbon Space VA20A, Siemens Healthcare GmbH (2022) Summary page 4.

## Most influential descendants
- K232856: Syngo Carbon Clinicals (2023), 1 descendant of its own
- K263048: Syngo Carbon Space (VA4) (2026), 0 descendants of its own
- K251059: Syngo Carbon Clinicals (VA41) (2025), 0 descendants of its own
- K240294: Syngo Carbon Enterprise Access (VA40A) (2024), 0 descendants of its own

## Indications for use
Syngo Carbon Space is a software intended to display medical data and to support the review and analysis of medical images by trained medical professionals. Syngo Carbon Space "Diagnostic Workspace" 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. Syngo Carbon Space "Physician Access" is indicated for display and rendering of medical data within healthcare institutions.

Source page: https://510kreport.com/device/K230561
Methodology: https://510kreport.com/methodology