510(k) clearance

Eden PACS

FDA 510(k) source

510(k) number

K261788

Applicant

Higia., Inc. d/b/a Eden

Decision date

Oct 21, 2026

Date received

May 29, 2026

Decision

Substantially Equivalent

Clearance type

Abbreviated

Product code

LLZ

Device type

System, Image Processing, Radiological

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Wilmington, DE, US