VersaViewer

FDA 510(k) K243651 · GE Medical Systems SCS

Substantially Equivalent

510(k) numberK243651

Submission

Device name
VersaViewer
Applicant
GE Medical Systems SCS
Buc, FR
Received
November 26, 2024
Decision date
April 21, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was VersaViewer cleared by the FDA?

VersaViewer (K243651) received a 510(k) decision of Substantially Equivalent on April 21, 2025, 146 days after the submission was received.

What is the product code of K243651?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.