vRad Viewer

FDA 510(k) K241879 · Virtual Radiologic Corporation

Substantially Equivalent

510(k) numberK241879

Submission

Device name
vRad Viewer
Applicant
Virtual Radiologic Corporation
Eden Prairie, MN, US
Received
June 28, 2024
Decision date
July 18, 2024
Decision
Substantially Equivalent (SESE)
Type
Special 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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Questions and answers

When was vRad Viewer cleared by the FDA?

vRad Viewer (K241879) received a 510(k) decision of Substantially Equivalent on July 18, 2024, 20 days after the submission was received.

What is the product code of K241879?

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