# K053148: CXR16

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Feb 17, 2006 after 99 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: 6 generations back to K944131 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.

## Indications for use
The CXR16 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/K053148
Methodology: https://510kreport.com/methodology