WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K260205

510(k) cleared

AS Software Version Asera

AS Software, LLC · Feb 19, 2026 · K260205

FDA cleared the AS Software Version Asera from AS Software, LLC on Feb 19, 2026 under K260205, a special 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 23, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for AS Software, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260205?

K260205 is the FDA 510(k) for AS Software Version Asera, submitted by AS Software, LLC. FDA's decision date was Feb 19, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the AS Software Version Asera?

AS Software, LLC, based in Englewood Cliffs, NJ, is the applicant of record for K260205.

How long did the K260205 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Feb 19, 2026, 27 days later.

← All decisions in February 2026