ImageGrid StreamVue— 510(k) K262143

Name: FDA 510(k) clearance K262143
Creator: U.S. Food and Drug Administration
Published: 2026-07-23

Substantially Equivalent

Candelis, Inc.

FDA 510(k) clearance K262143 for ImageGrid StreamVue, Substantially Equivalent on 2026-07-23. Applicant: Candelis, Inc.. Device class: 2.

Clearance details

Applicant: Candelis, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-06-25
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K262462 — TheraSphere 360 Y-90 Management Platform2026-07-24
K260500 — ResolutionMD2026-07-21
K262120 — Avara Viewer2026-07-10
K253899 — 3D-Anywhere2026-07-09
K261465 — INDIRA CLOUD VIEWER2026-07-06

More clearances from Candelis, Inc.

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K111694 — ASTRA2011-09-15
K092949 — IMAGEGRID RADIOLOGY VIEWER SYSTEM2009-10-08
K080333 — IMAGEGRID2008-02-22

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.