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510(k) K260205

AS Software Version Asera by AS Software, LLC — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2026
Date Received
January 23, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by AS Software, LLC

  • K051639 — AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM (August 2, 2005)

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