FDA.reportPublic FDA data

Falcon/Xpress

Primary DI
07290016880533
Brand
Falcon/Xpress
Company
VIASONIX LTD
Model
Falcon/Xpress
Device description
The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.
Published
2024-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
JOPTransducer, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOPTransducer, UltrasonicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242662000Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.2024-12-18JOP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016880533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016880533072900168805337290016880533

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533070236
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
072900168803974 MHz probe 4 MHz probePVC03302022-08-08
072900168804038 MHz probe 8 MHz probePVC03312022-08-08
07290016880540DolphinXpress2025-11-20
0729001688041010 MHz probe 10 MHz probePVC03322022-08-08
07290016880441Detachable PPG Clip sensorDetachable PPG Clip sensor2024-12-27
07290016880489Pressure Cuff Size 12LPressure Cuff Size 12L2023-06-29
07290016880496Pressure Cuff Size 2.5Pressure Cuff Size 2.52023-06-29
07290016880502Pressure Cuff Size 1.9Pressure Cuff Size 1.92023-06-29
07290016880519Pressure Cuff Size 1.6Pressure Cuff Size 1.62023-06-29
07290016880526Pressure Cuff Size 7Pressure Cuff Size 72023-06-29
07290016880465Pressure Cuff Size 10Pressure Cuff Size 102023-06-23
07290016880472Pressure Cuff Size 12Pressure Cuff Size 122023-06-25
07290016880229Dolphin/XF Robot AccessoryDolphin/XF Robot Accessory2021-03-31
0729001688007610 MHz probe 10 MHz probe2020-06-19
07290016880168Toe Clip PPG Sensor Toe Clip PPG Sensor PVC01432020-06-19
07290016880175Disk PPG sensor Disk PPG sensor 2020-06-19
07290016880182Fingerclip PPG sensor Fingerclip PPG sensor 2020-06-19
07290016880250LiteWalkLiteWalk2020-06-19
07290016880267LiteWalk SandalsLargePVC0268-L2020-06-19
07290016880274LiteWalk SandalsMediumPVC0268-M2020-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937029536CooperSurgical® Coopersurgical, Inc.JOP2026-04-10
G677H1V06VasoGuardCorVascularJOP2026-04-08
G677H1V08VasoGuardCorVascularJOP2026-04-08
G677H1V10VasoGuardCorVascularJOP2026-04-08
G677H2V02VasoGuardCorVascularJOP2026-04-08
G677H2V04VasoGuardCorVascularJOP2026-04-08
G677VG0201VasoGuardCorVascularJOP2026-04-08
G677VG0401VasoGuardCorVascularJOP2026-04-08
G677VG0601VasoGuardCorVascularJOP2026-04-08
G677VG0801VasoGuardCorVascularJOP2026-04-08
G677VG1001VasoGuardCorVascularJOP2026-04-08
00888937027815CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027839CooperSurgical® Coopersurgical, Inc.JOP2026-04-01
00888937027808CooperSurgical® Coopersurgical, Inc.JOP2026-01-23
00888937027822CooperSurgical® Coopersurgical, Inc.JOP2025-09-25
07290016880441Detachable PPG Clip sensorVIASONIX LTDJOP2024-12-27
07290016880489Pressure Cuff Size 12LVIASONIX LTDJOP2023-06-29
07290016880496Pressure Cuff Size 2.5VIASONIX LTDJOP2023-06-29
07290016880502Pressure Cuff Size 1.9VIASONIX LTDJOP2023-06-29
07290016880519Pressure Cuff Size 1.6VIASONIX LTDJOP2023-06-29
07290016880526Pressure Cuff Size 7VIASONIX LTDJOP2023-06-29
07290016880472Pressure Cuff Size 12VIASONIX LTDJOP2023-06-25
07290016880465Pressure Cuff Size 10VIASONIX LTDJOP2023-06-23
072900168803974 MHz probe VIASONIX LTDJOP2022-08-08
072900168804038 MHz probe VIASONIX LTDJOP2022-08-08
0729001688041010 MHz probe VIASONIX LTDJOP2022-08-08
008167870243193.9MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243268.1MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243338.3MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15
008167870243408.7MHz Pencil Probe 7 Foot ODU connectorPARKS MEDICAL ELECTRONICS, INC.JOP2022-05-15