# K052284: Reformat Gateway

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Oct 17, 2005 after 56 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954678 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.

## Indications for use
Reformat Gateway TM is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K052284
Methodology: https://510kreport.com/methodology