510(k) Report

FDA applicant

Higia., Inc. d/b/a Eden

Wilmington, DE1 decision2026–20260 recalls

FDA records 1 decision for Higia., Inc. d/b/a Eden (Wilmington, DE) in 2026: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Higia., Inc. d/b/a Eden’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Higia., Inc. d/b/a Eden by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

What has FDA decided for it lately?

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026

The one decision as Higia., Inc. d/b/a Eden →