Eden PACS— 510(k) K261788

Name: FDA 510(k) clearance K261788
Creator: U.S. Food and Drug Administration
Published: 2026-10-21

Substantially Equivalent

Higia., Inc. d/b/a Eden

FDA 510(k) clearance K261788 for Eden PACS, Substantially Equivalent on 2026-10-21. Applicant: Higia., Inc. d/b/a Eden. Device class: 2.

Clearance details

Applicant: Higia., Inc. d/b/a Eden
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-05-29
Decision date: 2026-10-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Wilmington, DE, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

view all

K263648 — Vitrea Advanced Visualization, Version 7.162026-10-29
K261763 — MIM KineticID2026-10-26
K261531 — PV-iCurve Pro2026-10-21
K263048 — Syngo Carbon Space (VA4)2026-09-29
K261874 — Syneris PACS v.1.0.1.02026-09-23

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.