# K163528: HITACHI Supria Whole-body X-ray CT System Phase 3

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Mar 3, 2017 after 77 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: 7 generations back to K031469 (2003). 7 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161748: SUPRIA w/guideShot Option, Hitachi Medical Systems America, Inc. (2016) Summary page 5.

## Most influential descendants
- K171738: Supria True64 (2017), 9 descendants of its own
- K190841: SCENARIA View (2019), 7 descendants of its own
- K200498: SCENARIA View (2020), 6 descendants of its own
- K213829: SCENARIA View (2022), 5 descendants of its own
- K231574: Scenaria View 4.2 (2023), 4 descendants of its own

## Indications for use
The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes. The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

Source page: https://510kreport.com/device/K163528
Methodology: https://510kreport.com/methodology