# K150595: SCENARIA Phase 3 Whole-body X-ray CT System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Oct 30, 2015 after 235 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: 6 generations back to K031469 (2003). 6 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 15 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.

## Most influential descendants
- 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
- K250370: SCENARIA View Phase 5.0 (2025), 2 descendants of its own

## Recalls of this device
- Oct 16, 2019 · Class II · Z-0271-2020: There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
- Jun 29, 2018 · Class II · Z-2839-2018: The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT

## Indications for use
The SCENARIA Phase 3 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 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 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/K150595
Methodology: https://510kreport.com/methodology