# K945668: KXO-80G

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Dec 27, 1994 after 40 days
- Product code: IZO (Generator, High-Voltage, X-Ray, Diagnostic)
- Device class: 1
- Regulation: 21 CFR 892.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060111: Iva (Mxa II Software Option) (2006), 6 descendants of its own
- 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

Source page: https://510kreport.com/device/K945668
Methodology: https://510kreport.com/methodology