# K123584: Syngo, CT Bone Reading

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 12, 2013 after 111 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: 9 generations back to K954678 (1996). 86 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112020: Syngo.CT Vascular Analysis, Siemens Medi Cal Solutions, Inc. (2011) Summary page 2.
- K072728: Syngo Multimodality Workplace, Siemens AG Medical Solutions (2008) Summary page 2.
- K120579: Somatom Definition Edge, Siemens Medical Systems, Inc. (2012) Summary page 2.

## Most influential descendants
- K193267: Al-Rad Companion (Musculoskeletal) (2020), 3 descendants of its own
- K213944: HealthOST (2022), 1 descendant of its own
- K183204: Bone VCAR (BVCAR) (2019), 1 descendant of its own
- K233080: HealthFLD (2024), 0 descendants of its own
- K223261: Open Rib (2023), 0 descendants of its own

## Indications for use
The syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. The software combines following digital image processing and visualization tools: multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT) geometric measurement tools (distance line, polyline, marker, arrow, angle) HU measurement tools (Pixel lens, ROI circle, ROl polygonal, ROl freehand, VOl sphere) curved MPR visualization (unfolded ribs and spine views), cross-section MPRs tools for creation and editing of anatomical centerline paths tools for creation and editing of anatomical labels The specific visualizations of spine and rib structures allow for easy manual identification and marking of pathologies such as bone lesions or fractures. Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.

Source page: https://510kreport.com/device/K123584
Methodology: https://510kreport.com/methodology