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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K260205
Device Name AS Software Version Asera
Applicant
AS Software, LLC
560 Sylvan Ave.
Englewood Cliffs,  NJ  07632
Applicant Contact Becky Piroga
Correspondent
AS Software, LLC
560 Sylvan Ave.
Englewood Cliffs,  NJ  07632
Correspondent Contact Becky Piroga
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/23/2026
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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