# K014240: Pronto

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Mar 22, 2002 after 86 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944131 (1995). 7 ancestors in all.
16 later devices descend from it; 1 cites 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)
- K991278: Philips Tomoscan AV-NT, Philips Medical Systems North America, Inc. (1999) Summary page 1.

## Most influential descendants
- K040902: Hitachi Presto (2004), 15 descendants of its own
- 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

## Indications for use
The intended use of the Pronto is to produce cross-sectional images of the body by using high-speed electronics to mathematically reconstruct axial slices using data produced by x-ray transmission data from the same axial plane taken at different angles. The system can then display, process and store the reconstructed slices.

Source page: https://510kreport.com/device/K014240
Methodology: https://510kreport.com/methodology