Cleared Special

Velacur One (LI-1100)

K251728 · Sonic Incytes Medical Corp · Radiology

Jun 2025

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K251728 is an FDA 510(k) clearance for the Velacur One (LI-1100), a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Sonic Incytes Medical Corp (Vancouver, CA). The FDA issued a Cleared decision on June 26, 2025, 21 days after receiving the submission on June 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K251728 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 2025
Decision Date	June 26, 2025
Days to Decision	21 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF