Avara Viewer

FDA 510(k) K262120 · Avara Software

Substantially Equivalent

510(k) numberK262120

Submission

Device name
Avara Viewer
Applicant
Avara Software
St Petersburg, FL, US
Received
June 23, 2026
Decision date
July 10, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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

Other 510(k)s with product code LLZ

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K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
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K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
K260588Cleerly LABSLLZ · Traditional Cleerly, Inc.07/29/2026SE
K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K2538993D-AnywhereLLZ · Traditional Provect.AI07/09/2026SE

Questions and answers

When was Avara Viewer cleared by the FDA?

Avara Viewer (K262120) received a 510(k) decision of Substantially Equivalent on July 10, 2026, 17 days after the submission was received.

What is the product code of K262120?

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