# K040902: Hitachi Presto

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Apr 21, 2004 after 14 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K944131 (1995). 8 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014240: Pronto, Hitachi Medical Systems America, Inc. (2002) Summary page 1.

## Most influential descendants
- K071806: Eclos Computed Tomography X-Ray System (2007), 12 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K170238: BodyTom Elite (2017), 4 descendants of its own
- K213649: BodyTom 64 (2022), 2 descendants of its own
- K131431: Airo CT System (2013), 2 descendants of its own

## Recalls of this device
- Apr 14, 2009 · Not classified · Z-1651-2009: Incorrect scale on image: A software error can occur if two (2) different Field-of-View (FOV) settings are registered in a protocol using Multi-Reconstruction. This could cause the image generated to 
- Nov 5, 2008 · Not classified · Z-0608-2009: Software error: The device has a software error that can result in a condition where the displayed image orientation does not match the display orientation markers (right-left reversal).
- Feb 21, 2006 · Not classified · Z-1078-06: The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, whe
- Feb 21, 2006 · Not classified · Z-1079-06: The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly 

## Indications for use
The Presto Computed Tomography system is an x-ray imaging device that produces cross-sectional images of the body at different angles. The system reconstructs, processes, displays, and stores the collected images. The device output can provide an aid to diagnosis when used by a qualified physician.

Source page: https://510kreport.com/device/K040902
Methodology: https://510kreport.com/methodology