# K213829: SCENARIA View

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Healthcare Corporation
- Decided: May 23, 2022 after 166 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K031469 (2003). 12 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200498: SCENARIA View, Hitachi Healthcare Americas (2020) Summary page 4.

## Most influential descendants
- K231574: Scenaria View 4.2 (2023), 4 descendants of its own
- K250370: SCENARIA View Phase 5.0 (2025), 2 descendants of its own
- K261229: SCENARIA View Phase 6.0 (2026), 0 descendants of its own
- K253836: FCT iStream Phase 2 (2026), 0 descendants of its own
- K233583: FCT iSTREAM Phase 1 (2024), 0 descendants of its own

## Recalls of this device
- Jul 12, 2022 · Class II · Z-1748-2022: 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 SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or FUJIFILM Healthcare Americas Corporation.

Source page: https://510kreport.com/device/K213829
Methodology: https://510kreport.com/methodology