# K192832: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Systems Corporation
- Decided: Feb 21, 2020 after 142 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K093891 (2010). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172188: Aquilion Prime SP, TSX-303B/1, v8.4, Toshiba Medical Systems Coroporation (2017) Summary page 5.

## Most influential descendants
- K203042: Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I (2020), 1 descendant of its own
- K211828: Aquilion Exceed LB (2021), 0 descendants of its own

## Recalls of this device
- Nov 9, 2020 · Class II · Z-0549-2021: A software problem has been identified which could result in the CT Scanner not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the C

## Indications for use
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Prime SP 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-IQ 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/K192832
Methodology: https://510kreport.com/methodology