# K981553: Automated Medical Report Writer

- Pathway: 510(k) (Traditional)
- Applicant: Woodson and Associates, LLC
- Decided: Sep 29, 1998 after 151 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Qasis 4.0 is an automated Medical Report Writer intended to be used with the Sahara Bone Sonometer to help communicate the results of the test in a uniform, accurate, and consistent manner. The results are expressed as QUI (Quantitative Ultrasound Index), estimated bone mineral density (BMD), T-score, and Z-score. The estimated BMD is calculated from the QUI. The results are also translated into one of the diagnostic categories — Normal, Osteopenia, or Osteoporosis — based upon the WHO criteria and the normative reference data base. There is standardized language for the estimated risk of fracture and for the therapeutic options which the attending physician may recommend.

Source page: https://510kreport.com/device/K981553
Methodology: https://510kreport.com/methodology