VUZE System

FDA 510(k) K232976 · Vuze Medical , Ltd.

Substantially Equivalent

510(k) numberK232976

Submission

Device name
VUZE System
Applicant
Vuze Medical , Ltd.
Tel Aviv, IL
Received
September 21, 2023
Decision date
May 9, 2024
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 VUZE System cleared by the FDA?

VUZE System (K232976) received a 510(k) decision of Substantially Equivalent on May 9, 2024, 231 days after the submission was received.

What is the product code of K232976?

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