# K151957: BOX DICOM Viewer

- Pathway: 510(k) (Special)
- Applicant: Box, Inc.
- Decided: Sep 1, 2015 after 47 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: 6 generations back to K954678 (1996). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132799: Clariso Pacs, Clariso, Inc. (2013) Summary page 4.

## Most influential descendants
- K200822: Braid (2020), 1 descendant of its own
- K231385: Rology Teleradiology Platform (v.1.22.1103) (2023), 0 descendants of its own
- K180549: ZED Link (2018), 0 descendants of its own

## Indications for use
The BOX DICOM Viewer™ is a software Teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. The BOX DICOM Viewer™ is used by hospitals, imaging centers, radiologist reading practices. Contraindications: The BOX DICOM Viewer™ is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

Source page: https://510kreport.com/device/K151957
Methodology: https://510kreport.com/methodology