Cleared Traditional

K262143 - ImageGrid StreamVue

K262143 is an FDA 510(k) clearance for ImageGrid StreamVue, manufactured by Candelis, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K262143 · Candelis, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
28d
Days
Class 2
Risk

K262143 is an FDA 510(k) clearance for the ImageGrid StreamVue. 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 Candelis, Inc. (Beverly Hills, US). The FDA issued a Cleared decision on July 23, 2026 after a review of 28 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 Candelis, Inc. devices

FDA 510(k) Submission Details - K262143

510(k) Number K262143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2026
Decision Date July 23, 2026
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 - LLZ System, Image Processing, Radiological

All 1753
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K262143.
RadioViewAI
K260936 · Neurocareai, Inc. (Dba Savelife.Ai) · Jul 2026
Cleerly LABS
K260588 · Cleerly, Inc. · Jul 2026
TheraSphere 360™ Y-90 Management Platform
K262462 · Boston Scientific Corporation · Jul 2026
ResolutionMD
K260500 · ResolutionMD, Inc. · Jul 2026
Avara Viewer
K262120 · Avara Software · Jul 2026
3D-Anywhere
K253899 · Provect.AI · Jul 2026