# K971054: Osteo CT for the Somatom AR Family and Plus 4 CT Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 13, 1997 after 81 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3D QCT Bone Mineral Densitometry: named in the summary without a submission number
- (no number) SOMATOM AR family, and Plus 4 CT scanners: named in the summary without a submission number

## Most influential descendants
- K163341: syngo.CT Extended Functionality (2017), 6 descendants of its own
- K173625: syngo.CT Clinical Extensions (2018), 5 descendants of its own
- K192402: syngo.CT Extended Functionality (2019), 4 descendants of its own
- K203699: syngo. CT Extended Functionalities (2021), 3 descendants of its own
- K214019: syngo.CT Extended Functionality (2022), 1 descendant of its own

## Indications for use
The Osteo CT is intended to be used for routine assessment of bone mineral content in the vertebral bodies of the lumbar and thoracical spine with high precision through the use of SOMATOM CT scanners. It is also applicable to assessment of changes in bone mineral content over time.

Source page: https://510kreport.com/device/K971054
Methodology: https://510kreport.com/methodology