Cleared Traditional

K243651 - VersaViewer

K243651 is the FDA 510(k) clearance for VersaViewer by GE Medical Systems SCS. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K243651 · GE Medical Systems SCS · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
146d
Days
Class 2
Risk

K243651 is an FDA 510(k) clearance for the VersaViewer. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on April 21, 2025 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all GE Medical Systems SCS devices

Submission Details

510(k) Number K243651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K243651.
uWS-Angio Basic
K243632 · Shanghai United Imaging Healthcare Co., Ltd. · May 2025
LUMYS (V1)
K243069 · Intradys · May 2025
MySpine WebPlanner
K243697 · Medacta International S.A. · Apr 2025
MySegmenter (v2.0.0)
K242647 · Mysegmenter Technologies, Inc. · Apr 2025
Merge Universal Viewer (MUV)
K250301 · Merge Healthcare Incorporated · Apr 2025
Horos Mobile
K242552 · Icat Solutions, Ltd. · Apr 2025