# K183291: Supria True64 Whole-Body X-Ray CT System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Healthcare Americas
- Decided: Feb 1, 2019 after 67 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: 9 generations back to K031469 (2003). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171738: Supria True64, Hitachi Healthcare Americas Corporation (2017) Summary page 4.

## Recalls of this device
- Jul 12, 2022 · Class II · Z-1749-2022: Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additiona
- Jul 12, 2022 · Class II · Z-1750-2022: Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additiona

## Indications for use
The Supria True64 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/K183291
Methodology: https://510kreport.com/methodology