# K201836: Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Jan 12, 2021 after 194 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K093891 (2010). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170019: Aquilion Lightning, TSX-036A/1, V8.4, Toshibamedical Systems Corporation (2017) Summary page 5.

## Most influential descendants
- K222819: Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i (2023), 3 descendants of its own
- K231281: Aquilion Serve (TSX-307A/1) V1.3 (2023), 2 descendants of its own
- K233334: Aquilion Serve SP (TSX-307B/1) V1.3 (2023), 1 descendant of its own
- K260078: Aquilion ServeSP (TSX-307B) V2.0 (2026), 0 descendants of its own

## Indications for use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. AiCE (Advanced Intelligent Clear-1Q Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen,pelvis, lung, cardiac, extremities, head and inner ear applications.

Source page: https://510kreport.com/device/K201836
Methodology: https://510kreport.com/methodology