# K120546: Aquilion Premium

- Pathway: 510(k) (Special)
- Applicant: Toshiba Medical Systems Corporation, Japan
- Decided: Jun 13, 2012 after 111 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K031469 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083282: Model TSX-301B Aquilion CT System, Toshiba America Medical Systems, In.C (2008) Summary page 1.

## Recalls of this device
- Mar 25, 2019 · Class II · Z-1721-2020: 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.
- May 8, 2015 · Class II · Z-0015-2016: If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

## Indications for use
This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head, with the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, pancreas, etc. The Aquilion has the capability to provide volume sets of the entire organ. These volume sets can be used to perform specialized studies, using indicated software/hardware, of the whole organ by a trained and qualified physician.

Source page: https://510kreport.com/device/K120546
Methodology: https://510kreport.com/methodology