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The Tracker / October 2026 / K261788

510(k) cleared

Eden PACS

Higia., Inc. d/b/a Eden · Oct 21, 2026 · K261788

FDA cleared the Eden PACS from Higia., Inc. d/b/a Eden on Oct 21, 2026 under K261788, a abbreviated 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 29, 2026. The decision came 145 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Higia., Inc. d/b/a Eden in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261788?

K261788 is the FDA 510(k) for Eden PACS, submitted by Higia., Inc. d/b/a Eden. FDA's decision date was Oct 21, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Eden PACS?

Higia., Inc. d/b/a Eden, based in Wilmington, DE, is the applicant of record for K261788.

How long did the K261788 review take?

FDA received the submission on May 29, 2026 and issued its decision on Oct 21, 2026, 145 days later.

← All decisions in October 2026