Cleared Traditional

LiveMedica Enterprise PACS

K253927 · Live Medica, LLC · Radiology
Feb 2026
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K253927 is an FDA 510(k) clearance for the LiveMedica Enterprise PACS, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Live Medica, LLC (Raleigh, US). The FDA issued a Cleared decision on February 6, 2026, 60 days after receiving the submission on December 8, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K253927 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2025
Decision Date February 06, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050