FFRangio

Primary DI
17290017855087
Brand
FFRangio
Company
CATHWORKS LTD
Model
FAU04000
Catalog number
FAU04000
Device description
The FFRangio System is a non invasive image based software device.
Published
2026-10-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K192442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192442000FFRangioCathworks, Ltd.2019-12-09QEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017855087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001785508717290017855087

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.

Contacts#

Phone, Email table
PhoneEmail
+972 586886608Ayelet.Peer@medtronic.com

Regulatory Flags#

DUNS number
600231478
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017855028FFRangioFAU01000FAU010002019-02-12
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
07290017855028FFRangioCATHWORKS LTDQEK2019-02-12
17290017855025FFRangioCATHWORKS LTDQEK2019-02-12