# K261465: Indira Cloud Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Indigo Technologies
- Decided: Jul 6, 2026 after 63 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: 10 generations back to K913770 (1991). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250181: AV Viewer, Philips Medical Systems Nederland B.V. (2025) Summary page 5.

## Indications for use
The Indira Cloud Viewer is a visualization software intended to process and display image and associated data in a clinical setting. The software displays images of different modalities and timepoints, and performs digital image processing, measurement, manipulation, quantification and communication. The Indira Cloud viewer is a web-based application and does not perform automated diagnosis and is not intended to replace clinical judgment.

Source page: https://510kreport.com/device/K261465
Methodology: https://510kreport.com/methodology