JiveX

FDA 510(k) K181964 · Visus Health IT GmbH

Substantially Equivalent

510(k) numberK181964

Submission

Device name
JiveX
Applicant
Visus Health IT GmbH
Bochum, DE
Received
July 23, 2018
Decision date
October 23, 2018
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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More from Avara Software

510(k)DeviceDecision
K231041JiveX (Model Number / Release: 5.4)LLZ · Traditional 07/14/2023SE
K212321JiveX (Model Number / Release: 5.3)LLZ · Traditional 09/23/2021SE
K200703JiveXLLZ · Traditional 04/14/2020SE

Questions and answers

When was JiveX cleared by the FDA?

JiveX (K181964) received a 510(k) decision of Substantially Equivalent on October 23, 2018, 92 days after the submission was received.

What is the product code of K181964?

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