# K203411: syngo.CT Skull Unfolding

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 22, 2021 after 245 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954678 (1996). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123584: Syngo, CT Bone Reading, Siemens Medical Solutions USA, Inc. (2013) Summary page 5.

## Indications for use
syngo.CT Skull Unfolding provides curved MIP images of skull and brain surface for visual assessment by a radiologist.

Source page: https://510kreport.com/device/K203411
Methodology: https://510kreport.com/methodology