AS Software Version Asera

FDA 510(k) K260205 · AS Software, LLC

Substantially Equivalent

510(k) numberK260205

Submission

Device name
AS Software Version Asera
Applicant
AS Software, LLC
Englewood Cliffs, NJ, US
Received
January 23, 2026
Decision date
February 19, 2026
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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Questions and answers

When was AS Software Version Asera cleared by the FDA?

AS Software Version Asera (K260205) received a 510(k) decision of Substantially Equivalent on February 19, 2026, 27 days after the submission was received.

What is the product code of K260205?

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