# K101888: Scenaria Whole-Body X-Ray CT System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Apr 8, 2011 after 275 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K031469 (2003). 4 ancestors in all.
15 later devices descend from it; 1 cites 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)
- K080211: Model TSX-101A/H/I Aquilion 32/64 SP CT System, Toshiba America Medical Systems, In.C (2008) Summary page 2.

## Most influential descendants
- K123509: Scenaria Phase 2 Whole-Body X-Ray CT System (2013), 14 descendants of its own
- 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

## 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 30, 2015 · Class II · Z-2392-2016: The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to r
- May 4, 2012 · Class II · Z-2037-2012: Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued f

## Indications for use
The Scenadia system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenadia can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Volume datasets acquired by the Scenaria can be transferred to external devices via a DICOM standard interface.

Source page: https://510kreport.com/device/K101888
Methodology: https://510kreport.com/methodology