# K231385: Rology Teleradiology Platform (v.1.22.1103)

- Pathway: 510(k) (Traditional)
- Applicant: Rology, Inc.
- Decided: Sep 20, 2023 after 131 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: 12 generations back to K954874 (1996). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200822: Braid, Braid.Health (2020) Summary page 5.

## Indications for use
The Rology Teleradiology Platform is a Web-based software system used to receive, view and manipulate DICOM images, schedule, provide textual reports, organize, store, and make such information available. When images are reviewed and used as an element of diagnosis, it is the responsibility of the qualified clinician to determine if the image quality is suitable for their clinical application. The Rology Teleradiology Platform is intended to be used by clinicians qualified in the use of radiological images for interpretation/diagnosis. Contraindications: Rology Teleradiology Platform is not intended for the acquisition of mammographic image data for primary diagnosis.

Source page: https://510kreport.com/device/K231385
Methodology: https://510kreport.com/methodology