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510(k) K242662

Device
Falcon/Xpress (Falcon/Xpress)
Applicant
Viasonix , Ltd.
510(k) number
K242662
Product code
JOP
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-18
Date received
2024-09-04
Regulation
870.2880
Classification name
Transducer, Ultrasonic
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dan Manor
Address
10 Hamelacha St. Ra'Anana IL 4366105 4366105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JOP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLC2024-07-19
K153762Smartdop XT6Koven Technology, Inc.2016-05-25
K131623SMARTDOP XTKoven Technology, Inc.2014-01-17
K131860VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDINGUs Vascular, LLC2013-09-27
K111416FALCONViasonix , Ltd.2011-07-15
K071730STUDIODOP VICORDERSkidmore Medical, Limited2007-12-20
K010482ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1Echocath, Inc.2001-03-20
K002766NICOLET VASOGUARDNicolet Biomedical2000-11-30
K990642ECHOFLOW DOPPLER BLOOD VELOCITY METEREchocath, Inc.1999-09-16
K925078SPECTRADOPBennett and Assoc., Inc.1995-07-17
K934638REUSABLE CW DOPPLER PROBES: MODELS P8M05S8A, P8M05N5A, & LCW-8Koven Technology, Inc.1994-05-13
K912409MODEL HD-207 BIDIRECTIONAL VELOCITY METERKoven and Assoc., Inc.1991-12-23
K911320EXTRAVASCULAR DOPPLER (EVD) ULTRA BLOOD FLOW PROBEApplied Biometrics, Inc.1991-12-18
K910281INTRAVASCULAR IMAGING SYSTEM/MODIFIEDIntertherapy, Inc.1991-05-13
K905157FLOSCOPE VASCULAR LAB.Advance Medical Device, Inc.1991-03-15