# K150565: Supria Whole-body X-ray CT System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Sep 30, 2015 after 208 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: 6 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)
- K123509: Scenaria Phase 2 Whole-Body X-Ray CT System, Hitachi Medical Systems America, Inc. (2013) Summary page 5.

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

Source page: https://510kreport.com/device/K150565
Methodology: https://510kreport.com/methodology