# K984178: Pronosco X-Posure System

- Pathway: 510(k) (Traditional)
- Applicant: Torsana Osteoporosis Diagnostics A/S
- Decided: Feb 18, 1999 after 90 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913321 (1991). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913321: Hologic QDR-2000 X-Ray Bone Densitometer, Hologic, Inc. (1991) Summary page 2.
- K973104: Norland Model Pdexa Bone Densitometer, Norland Corp. (1998) Summary page 2.
- (no number) Norland Medical Systems’ Norland 178 Bone Mineral Analyzer: named in the summary without a submission number
- (no number) Compumed, Inc.’s Osteogram: named in the summary without a submission number

## Most influential descendants
- K082402: Osdx Hip BMD System (2008), 6 descendants of its own
- K121716: TBS Insight (2012), 5 descendants of its own
- K152299: TBS iNsight (2016), 4 descendants of its own
- K191112: GEHC DXA Bone Densitometers with enCORE version 18 (2019), 2 descendants of its own
- K252718: Lunar Astra (2026), 0 descendants of its own

## Indications for use
The Pronosco X-posure System™ is intended for use to estimate BMD in the forearm and to assess increased risk of osteoporotic fractures according to World Health Organization (“WHO”) criteria. The device is specifically indicated for use to: (1) assist the physician in diagnosing subjects who have already been identified to be at risk of suffering from osteoporosis, together with other known risk factors (i.e., prior history of fractures, advanced age, low body weight, lack of physical exercise, lack of exposure to sunlight, insufficient dietary intake of calcium and vitamin D, and smoking); and (2) compare the BMD estimate with reference populations of young normals and age matched normals to compute T-scores and Z-scores, respectively.

Source page: https://510kreport.com/device/K984178
Methodology: https://510kreport.com/methodology