Cleared Special

K261405 - ANDI 2.2 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K261405 · Imeka Solutions, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
29d
Days
Class 2
Risk

K261405 is an FDA 510(k) clearance for the ANDI 2.2. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Imeka Solutions, Inc. (Sherbrooke, CA). The FDA issued a Cleared decision on May 28, 2026 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Imeka Solutions, Inc. devices

Submission Details

510(k) Number K261405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2026
Decision Date May 28, 2026
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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 Consultant

Eversana
Kory Dillman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QIH Automated Radiological Image Processing Software

All 295
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K261405.
OrthoGrid Hip AI® 4.0
K260077 · OrthoGrid Systems, Inc. · May 2026
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
K260324 · Canon Medical Informatics, Inc. · May 2026
BAC
K254131 · DeepHealth, Inc. · May 2026
MSK Go
K260234 · Smart Alfa Teknoloji San. Ve Tic. A.S. · May 2026
Neurophet SCALE PET
K252563 · Neurophet., Inc. · May 2026
SubtleHD-CT (1.x)
K254120 · Subtle Medical, Inc. · May 2026