Cleared Traditional

K261465 - INDIRA CLOUD VIEWER

K261465 is an FDA 510(k) clearance for INDIRA CLOUD VIEWER, manufactured by INDIGO TECHNOLOGIES. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K261465 · INDIGO TECHNOLOGIES · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
63d
Days
Class 2
Risk

K261465 is an FDA 510(k) clearance for the INDIRA CLOUD VIEWER. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by INDIGO TECHNOLOGIES (Bogota, CO). The FDA issued a Cleared decision on July 6, 2026 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all INDIGO TECHNOLOGIES devices

FDA 510(k) Submission Details - K261465

510(k) Number K261465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2026
Decision Date July 06, 2026
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1761
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K261465.
ResolutionMD
K260500 · ResolutionMD, Inc. · Jul 2026
Avara Viewer
K262120 · Avara Software · Jul 2026
3D-Anywhere
K253899 · Provect.AI · Jul 2026
MiPACS V5 (1.0.0)
K260231 · Apryse Software Corp · Jun 2026
Perfusion Measurement Platform v1
K253421 · Quantified Imaging Limited · Jun 2026
2D Hip Planning Software
K261352 · One Ortho · Jun 2026