# K172188: Aquilion Prime SP, TSX-303B/1, v8.4

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba Medical Systems Coroporation
- Decided: Oct 6, 2017 after 78 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: 5 generations back to K093891 (2010). 8 ancestors in all.
3 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)
- K141741: Aquilion Prime, V6.00, Toshibamedical Systems Corporation (2014) Summary page 5.
- K170019: Aquilion Lightning, TSX-036A/1, V8.4, Toshibamedical Systems Corporation (2017) Summary page 5.

## Most influential descendants
- K192832: Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i (2020), 2 descendants of its own
- 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
- Mar 25, 2019 · Class II · Z-1724-2020: Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot.

## 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.

Source page: https://510kreport.com/device/K172188
Methodology: https://510kreport.com/methodology