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FFRangio System FAU04000

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref FAU04000

by CathWorks Ltd.

Identity

Trade Name
FFRangio System EUDAMED
FFRangio EUDAMEDFDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Device Name
FFRangio System EUDAMED
The FFRangio System is a non invasive image based software device FDA UDI
Model / Reference
FAU04000 EUDAMEDFDA UDI
Description
The FFRangio System is a non invasive image based software device FDA UDI

Identifiers

Catalog Number
FAU04000 FDA UDI
Primary DI / UDI-DI
07290017855059 EUDAMEDFDA UDI
Basic UDI-DI
7290017855FAU04000C3 EUDAMED
B-07290017855059 EUDAMED
FDA Product Code
QEK FDA UDI
EMDN Code
Z11039092 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
GMDN Term
Diagnostic x-ray digital imaging system workstation FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.1415 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The FFRangio System FAU04000 is a diagnostic device classified under nomenclature code Z11039092, designed for measuring physiological function. It provides intraprocedural assessment of coronary artery physiology by analyzing routine angiographic images using artificial intelligence and computational methods, eliminating the need for invasive pressure wires or pharmacological stimulation.

This non-sterile, single-use device is intended for use in cardiac catheterization laboratories. Supplied as a software-based system, it requires compatibility with existing angiographic imaging equipment and is regulated under FDA 510K clearance, MDD, and MDR. The system is not implantable, reusable, or associated with latex or animal-derived substances, and its use is governed by the manufacturer’s instructions and applicable regulatory standards.

Frequently asked questions

What is the FFRangio System used for in a cardiac catheterization lab and how does it differ from traditional methods?

The FFRangio System is designed to assess coronary artery physiology during procedures by analyzing standard angiographic images with artificial intelligence and computational methods. Unlike traditional methods, it eliminates the need for invasive pressure wires or pharmacological stress tests, providing functional insights without additional hardware or stimulation.

Is the FFRangio System reusable or does it require sterilization between uses?

The FFRangio System is a single-use, non-sterile software-based device. It is not intended for reuse or sterilization, and its use is governed by the manufacturer’s instructions for one-time procedural application.

What types of imaging equipment must be compatible with the FFRangio System for it to function?

The FFRangio System requires compatibility with existing angiographic imaging equipment used in cardiac catheterization labs. Since it relies on routine angiographic images for analysis, it integrates with standard X-ray systems already in place for coronary angiography.

Does the FFRangio System contain any animal-derived substances or latex, and is it implantable?

No, the FFRangio System does not contain animal-derived substances or latex, and it is explicitly not designed for implantation. It is a standalone software solution for intraprocedural analysis, remaining external to the patient throughout use.

How do I identify the correct version of the FFRangio System for purchase, and what regulatory pathways does it follow?

The correct version of the FFRangio System is identified by the model number FAU04000 and the UDI 7290017855FAU04000C3. It is regulated under FDA 510K clearance, MDD, and MDR, ensuring compliance with European and U.S. medical device standards. Always verify the UDI and version number to confirm compatibility with your facility’s requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CathWorks FFRangio System, BEYOND - CathWorks FFRangio System, CathWorks FFRangio™ System | Medtronic, Medtronic completes acquisition of CathWorks, expanding its leadership ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
CathWorks Ltd.
EUDAMED SRN
IL-MF-000021861
Authorised Representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Sources (4)

  • EUDAMED 0636f18f-aff0-4166-99e9-25b900feb639 61 fields · synced Sep 18, 2026
  • EUDAMED e49c4aca-4263-4b25-a087-99ad7535534f 61 fields · synced May 19, 2026
  • FDA UDI 24341169-aeec-4c08-800d-57341aa96f48 35 fields · synced May 30, 2026
  • FDA 510(k) K192442 1 fields · synced May 18, 2026