# K060111: Iva (Mxa II Software Option)

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Apr 24, 2006 after 97 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 K945668 (1994). 3 ancestors in all.
6 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)
- K941362: Bone Mineral Densitometer, Hologic, Inc. (1995) Summary page 1.
- K992775: Option for the QDR Bone Densitometer, Models QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1999) Summary page 1.
- K945668: KXO-80G, Toshiba America Medical Systems, In.C (1994) Summary page 2.

## Most influential descendants
- K130277: Single Energy (SE) Femur Exams (2013), 5 descendants of its own
- K161682: GE Lunar DXA Bone Densitometers with enCORE version 17 (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
- K251022: 3D-Shaper (2025), 0 descendants of its own

## Indications for use
IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.

Source page: https://510kreport.com/device/K060111
Methodology: https://510kreport.com/methodology