# K103475: Spineanalyer Model Sapoc

- Pathway: 510(k) (Traditional)
- Applicant: Optasia Medical
- Decided: Jan 5, 2011 after 42 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: 2 generations back to K950611 (1995). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023554: Dual-Energy Vertebral Assessment View Software, Ge Lunar Corp. (2002) Summary page 2.

## Most influential descendants
- K171435: VirtuOst Vertebral Fracture Assessment (2018), 0 descendants of its own
- K120288: Orthocad Software Option (2012), 0 descendants of its own

## Indications for use
The Optasia Medical SpineAnalyzer T M is intended for the visualization or quantitative assessment of vertebral body deformities between levels T4 and L4 of the thoracic and lumbar spine in adult patients at risk of osteoporotic fracture. The qualified medical practitioner uses the device to calculate vertebral deformity ratios derived from the interactive placement of morphometry markers. Deformity grades are then calculated using criteria published by Genant t . Additionally, the qualified medical practitioner can record a manual Genant Semi-Quantitative score based on visual assessment. The qualified medical practitioner may use the deformity ratios and deformity grades to assist in the diagnosis of vertebral fracture and may, along with knowledge of patient history, apply medical expertise and best practice clinical judgment to determine if therapeutic intervention is indicated.

Source page: https://510kreport.com/device/K103475
Methodology: https://510kreport.com/methodology