Merge PACS

FDA 510(k) K192455 · Merge Healthcare Incorporated

Substantially Equivalent

510(k) numberK192455

Submission

Device name
Merge PACS
Applicant
Merge Healthcare Incorporated
Hartland, WI, US
Received
September 9, 2019
Decision date
October 17, 2019
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

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K250301Merge Universal Viewer (MUV)LLZ · Traditional 04/14/2025SE
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K203104IBM iConnect AccessLLZ · Traditional 01/26/2021SE
K192276Merge CardioLLZ · Traditional 09/20/2019SE
K182290IBM iConnect AccessLLZ · Traditional 09/25/2018SE
K173475Merge PACSLLZ · Traditional 12/08/2017SE
K152864Merge HemoDQK · Traditional 04/07/2016SE

Questions and answers

When was Merge PACS cleared by the FDA?

Merge PACS (K192455) received a 510(k) decision of Substantially Equivalent on October 17, 2019, 38 days after the submission was received.

What is the product code of K192455?

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