Cleared Special

AS Software Version Asera (K260205) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260205 · AS Software, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
27d
Days
Class 2
Risk

K260205 is an FDA 510(k) clearance for the AS Software Version Asera. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by AS Software, LLC (Englewood Cliffs, US). The FDA issued a Cleared decision on February 19, 2026 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all AS Software, LLC devices

Submission Details

510(k) Number K260205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K260205.
TheraSphere 360™ Y-90 Management Platform
K260479 · Boston Scientific Corporation · Mar 2026
Mimics Thoracic Planner
K251964 · Materialise NV · Mar 2026
SKIA-Head (Model: SKIA-ST00)
K253486 · Skia, Inc. · Feb 2026
LAIA XR
K251577 · Augmented Reality Software S.L. · Feb 2026
LiveMedica Enterprise PACS
K253927 · Live Medica, LLC · Feb 2026
View
K253639 · Ge Healthcare · Jan 2026