Cleared Traditional

VersaViewer

K243651 · GE Medical Systems SCS · Radiology
Apr 2025
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K243651 is an FDA 510(k) clearance for the VersaViewer, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on April 21, 2025, 146 days after receiving the submission on November 26, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K243651 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2024
Decision Date April 21, 2025
Days to Decision 146 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