# K123509: Scenaria Phase 2 Whole-Body X-Ray CT System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Mar 29, 2013 after 136 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: 5 generations back to K031469 (2003). 5 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101888: Scenaria Whole-Body X-Ray CT System, Hitachi Medical Systems America, Inc. (2011) Summary page 1.

## Most influential descendants
- K161748: SUPRIA w/guideShot Option (2016), 11 descendants of its own
- K163528: HITACHI Supria Whole-body X-ray CT System Phase 3 (2017), 10 descendants of its own
- K171738: Supria True64 (2017), 9 descendants of its own
- K150595: SCENARIA Phase 3 Whole-body X-ray CT System (2015), 8 descendants of its own
- K190841: SCENARIA View (2019), 7 descendants of its own

## Indications for use
The SCENARIA Phase 2 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 SCENARIA Phase 2 can be post processed by the SCENARIA Phase 2 to provide additional information. Post processing capabilities included in the SCENARIA Phase 2 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 2 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/K123509
Methodology: https://510kreport.com/methodology