# K071806: Eclos Computed Tomography X-Ray System

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Aug 28, 2007 after 57 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: 6 generations back to K944131 (1995). 9 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040902: Hitachi Presto, Hitachi Medical Systems America, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K242811: BodyTom 64 (2025), 1 descendant of its own

## Recalls of this device
- Apr 14, 2009 · Not classified · Z-1652-2009: 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 

## Indications for use
The ECLOS 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 and is intended for general purpose CT applications.

Source page: https://510kreport.com/device/K071806
Methodology: https://510kreport.com/methodology