Cleared Special

AS Software Version Asera

K260205 · AS Software, LLC · Radiology

Feb 2026

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K260205 is an FDA 510(k) clearance for the AS Software Version Asera, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by AS Software, LLC (Englewood Cliffs, US). The FDA issued a Cleared decision on February 19, 2026, 27 days after receiving the submission on January 23, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K260205 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2026
Decision Date	February 19, 2026
Days to Decision	27 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF