Identity
- Trade Name
- FFRangio FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- FAU01000 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- FAU01000 FDA UDI
- Primary DI / UDI-DI
- 07290017855028 FDA UDI
- 510(k) Number
- K182149 FDA UDI
- FDA Product Code
- QEK FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1415 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Diagnostic x-ray digital imaging system workstation
FFRangio by Cathworks Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic x-ray digital imaging system workstation.
- DelWorks — DEL MEDICAL, INC. · Class II
- LessRay — Nuvasive, Inc. · Class II
- LessRay — Nuvasive, Inc. · Class II
- Digital Expert Access — GE Healthcare · Class II
- LessRay — Nuvasive, Inc. · Class II
- IMAGE DIAGNOSTICS, INC — IMAGE DIAGNOSTICS, INC. · Class I
- PULSE — Nuvasive, Inc. · Class II
- LessRay — Nuvasive, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cathworks Ltd
Sources (1)
- FDA UDI 9492804a-c514-4f1c-9556-ac031daac30d 37 fields · synced May 31, 2026