Cleared Traditional

Falcon/Xpress (Falcon/Xpress)

K242662 · Viasonix , Ltd. · Cardiovascular
Dec 2024
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K242662 is an FDA 510(k) clearance for the Falcon/Xpress (Falcon/Xpress), a Transducer, Ultrasonic (Class II — Special Controls, product code JOP), submitted by Viasonix , Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on December 18, 2024, 105 days after receiving the submission on September 4, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2880.

Submission Details

510(k) Number K242662 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2024
Decision Date December 18, 2024
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOP — Transducer, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2880