INDIRA CLOUD VIEWER— 510(k) K261465

Name: FDA 510(k) clearance K261465
Creator: U.S. Food and Drug Administration
Published: 2026-07-06

Substantially Equivalent

INDIGO TECHNOLOGIES

FDA 510(k) clearance K261465 for INDIRA CLOUD VIEWER, Substantially Equivalent on 2026-07-06. Applicant: INDIGO TECHNOLOGIES. Device class: 2.

Summary

INDIGO TECHNOLOGIES' INDIRA CLOUD VIEWER is filed under LLZ, radiological image processing systems. The record doesn't describe what the viewer does beyond that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

INDIGO TECHNOLOGIES filed from Bogota, Colombia. The decision came 63 calendar days after FDA received it (May 4 to July 6, 2026).

Clearance details

Applicant: INDIGO TECHNOLOGIES
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-05-04
Decision date: 2026-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bogota, CO

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.