# K240294: Syngo Carbon Enterprise Access (VA40A)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare GmbH
- Decided: May 23, 2024 after 112 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 4.

## Indications for use
Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions

Source page: https://510kreport.com/device/K240294
Methodology: https://510kreport.com/methodology