# K213944: HealthOST

- Pathway: 510(k) (Traditional)
- Applicant: Nanoxai, Ltd.
- Decided: Apr 22, 2022 after 126 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: 11 generations back to K954678 (1996). 88 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193267: Al-Rad Companion (Musculoskeletal), Siemens Medical Solutions USA, Inc. (2020) Summary page 4.

## Most influential descendants
- K233080: HealthFLD (2024), 0 descendants of its own

## Indications for use
HealthOST is an image processing software that provides qualitative and quantitative analysis of the spine from CT images to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine. The HealthOST software provides the following functionality: -Labelling of T1-L4 vertebrae -Measurement of height loss in each vertebra (T1-L4) -Measurement of the mean Hounsfield Units (HU) in volume of interest within vertebra (T11-L4) HealthOST is indicated for use in patients aged 50 and over undergoing CT scan for any clinical indication, that includes at least four vertebrae in the T1-L4 portion of the spine (for vertebral height loss) and T11-L4 (for bone attenuation) portions of the spine. The device is indicated for FBP-reconstructed images only.

Source page: https://510kreport.com/device/K213944
Methodology: https://510kreport.com/methodology