Lightning Viewer

FDA 510(k) K242362 · Nexsys Electronics Inc. Dba Medweb

Substantially Equivalent

510(k) numberK242362

Submission

Device name
Lightning Viewer
Applicant
Nexsys Electronics Inc. Dba Medweb
Burlingame, CA, US
Received
August 9, 2024
Decision date
December 20, 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 Lightning Viewer cleared by the FDA?

Lightning Viewer (K242362) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 133 days after the submission was received.

What is the product code of K242362?

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