# K200822: Braid

- Pathway: 510(k) (Traditional)
- Applicant: Braid.Health
- Decided: Aug 13, 2020 after 136 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: 11 generations back to K954874 (1996). 88 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151957: BOX DICOM Viewer, Box, Inc. (2015) Summary page 4.
- K170434: Enterprise Imaging XERO Viewer 8.1, Agfa Healthcare N.V. (2017) Summary page 4.

## Most influential descendants
- K231385: Rology Teleradiology Platform (v.1.22.1103) (2023), 0 descendants of its own

## Indications for use
Braid 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. Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices. Braid can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. Braid mobile diagnostic use is not intended for the display of mammography images for diagnosis. When images are reviewed and use as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Contraindications: Braid 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/K200822
Methodology: https://510kreport.com/methodology