HPACS— 510(k) K250039

Name: FDA 510(k) clearance K250039
Creator: U.S. Food and Drug Administration
Published: 2025-10-03

Substantially Equivalent

Healthhub

FDA 510(k) clearance K250039 for HPACS, Substantially Equivalent on 2025-10-03. Applicant: Healthhub. Device class: 2.

Clearance details

Applicant: Healthhub
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-01-08
Decision date: 2025-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K262449 — AdvaView2026-08-14
K261916 — NeuroQuant PET2026-08-12
K260936 — RadioViewAI2026-07-31
K260588 — Cleerly LABS2026-07-29

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.