AS Software Version Asera— 510(k) K260205

Name: FDA 510(k) clearance K260205
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

AS Software, LLC

FDA 510(k) clearance K260205 for AS Software Version Asera, Substantially Equivalent on 2026-02-19. Applicant: AS Software, LLC. Device class: 2.

Summary

AS Software's device is named AS Software Version Asera and is filed under product code LLZ (System, Image Processing, Radiological). The record doesn't describe the software beyond that name and code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).

AS Software filed from Englewood Cliffs, New Jersey. The substantially equivalent decision came 27 calendar days after receipt (January 23 to February 19, 2026).

Clearance details

Applicant: AS Software, LLC
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-01-23
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Englewood Cliffs, NJ, US

Download summary PDF View on FDA.gov ↗

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K261874 — Syneris PACS v.1.0.1.02026-09-23
K262442 — HipStudio Analysis2026-09-22
K261855 — Elucid PlaqueIQ2026-09-18
K254214 — OOOPDS2026-09-15

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.