FDA 510(k)

Falcon/Xpress (Falcon/Xpress)

K-Number: K242662 · 2024-12-18

Decision Date2024-12-18

Product CodeJOP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Falcon/Xpress (Falcon/Xpress) is the device name listed in this FDA 510(k) record. The listed applicant is Viasonix , Ltd.. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K242662. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Falcon/Xpress (Falcon/Xpress)?

Falcon/Xpress (Falcon/Xpress) is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Viasonix , Ltd.. The 510(k) number is K242662.

When did Falcon/Xpress (Falcon/Xpress) receive FDA 510(k) clearance?

Falcon/Xpress (Falcon/Xpress) received FDA 510(k) clearance on 2024-12-18, under 510(k) number K242662.

Who is the listed applicant for Falcon/Xpress (Falcon/Xpress)?

The FDA 510(k) record lists Viasonix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Falcon/Xpress (Falcon/Xpress)?

The FDA product code for Falcon/Xpress (Falcon/Xpress) is JOP.

Other records listing Viasonix , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory K192607LiteWalk K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAX K170859Dolphin/IQ and Dolphin/4D

Related Devices (Code: JOP)

K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLC K153762Smartdop XT6Koven Technology, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.