FDA.report

510(k) K260205

Device
AS Software Version Asera
Applicant
AS Software, LLC
510(k) number
K260205
Product code
LLZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-19
Date received
2026-01-23
Regulation
892.2050
Classification name
System, Image Processing, Radiological
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Becky Piroga
Address
560 Sylvan Ave. Englewood Cliffs NJ US 07632 07632

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00860010575321AS SoftwareAs Software, LLC2026-03-10

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