LiveMedica Enterprise PACS— 510(k) K253927

Name: FDA 510(k) clearance K253927
Creator: U.S. Food and Drug Administration
Published: 2026-02-06

Substantially Equivalent

Live Medica, LLC

FDA 510(k) clearance K253927 for LiveMedica Enterprise PACS, Substantially Equivalent on 2026-02-06. Applicant: Live Medica, LLC. Device class: 2.

Summary

Live Medica's LiveMedica Enterprise PACS is filed under product code LLZ (System, Image Processing, Radiological). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Live Medica filed from Raleigh, North Carolina. Review took 60 calendar days (December 8, 2025 to February 6, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Live Medica, LLC
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-08
Decision date: 2026-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K263048 — Syngo Carbon Space (VA4)2026-09-29
K261874 — Syneris PACS v.1.0.1.02026-09-23
K262442 — HipStudio Analysis2026-09-22
K261855 — Elucid PlaqueIQ2026-09-18
K254214 — OOOPDS2026-09-15

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.