FFRangio

Primary DI
07290017855028
Brand
FFRangio
Company
CATHWORKS LTD
Model
FAU01000
Catalog number
FAU01000
Device description
The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative analysis of ‎functional significance of a coronary ‎lesion, similar to invasive FFR (Fractional Flow ‎Reserve), and a qualitative three-dimensional model of ‎the demonstrated coronary ‎arteries, during routine PCI procedure. The FFRangio™ System performs ‎all required ‎processing and calculations based only on angiography images and hemodynamics ‎‎information that are acquired during the coronary catheterization procedure.‎
Published
2019-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEKAngiographic Coronary Vascular Physiologic Simulation Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEKAngiographic Coronary Vascular Physiologic Simulation SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182149000FFRangio SystemCathworks, Ltd.2018-12-19QEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017855025PackageGS11In Commercial Distribution
07290017855028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001785502517290017855025
07290017855028072900178550287290017855028

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstationA freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-7 Degrees Fahrenheit140 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
949-330-6900Jim.corbett@cath.works
949-330-6900eleanor.jackson@cath.works

Regulatory Flags#

DUNS number
600231478
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017855059FFRangioFAU04000FAU040002019-12-26
17290017855056FFRangioFAU0400FAU04002019-12-26
17290017855025FFRangioFAU01000FAU010002019-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290017855059FFRangioCATHWORKS LTDQEK2019-12-26
17290017855056FFRangioCATHWORKS LTDQEK2019-12-26
17290017855025FFRangioCATHWORKS LTDQEK2019-02-12