UroNav Version 2.0
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- UroNav EUDAMEDInvivo FDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- UroNav EUDAMEDUroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. FDA UDI
- Model / Reference
- 784026 EUDAMEDFDA UDI
- Description
- UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838089648 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838089648 EUDAMED
- 510(k) Number
- K153073 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)FDA UDI
- EMDN Code
- Z11040182 ULTRASOUND SCANNERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The UroNav Version 2.0 is a Magnetic Resonance Imaging (MRI) compatible navigation system designed for real-time tracking and guidance during urological procedures. It integrates with MRI systems to provide precise spatial orientation and localization of instruments or markers within the urinary tract, enhancing procedural accuracy and reducing fluoroscopy exposure.
This device is supplied as a reusable system, intended for use in MRI-compatible operating rooms or procedural suites. It requires calibration and compatibility with MRI scanners, adhering to strict electromagnetic interference (EMI) standards. Authorized under FDA 510K clearance (K153073) and MDD compliance, it is classified under product code LLZ and reviewed by the Radiology Advisory Committee. Sterility is not applicable, as the system is not single-use.
Frequently asked questions
Is the UroNav (Version 2.0) system designed for single-use or can it be reused in multiple procedures?
The UroNav (Version 2.0) is explicitly designed as a reusable system, meaning it is intended for repeated use across multiple urological procedures in MRI-compatible settings. Since it is not sterile-packaged or labeled for single-use, it must be properly cleaned, calibrated, and maintained between uses to ensure accuracy and safety. Sterility is not applicable to this device.
What types of urological procedures can the UroNav (Version 2.0) assist with, and how does it improve safety?
The UroNav (Version 2.0) is an MRI-compatible navigation system that provides real-time tracking and spatial guidance for instruments or markers within the urinary tract. It enhances procedural accuracy during urological interventions—such as biopsies, stone removal, or tumor ablation—by reducing reliance on fluoroscopy, thereby lowering patient radiation exposure while improving precision.
How does the UroNav (Version 2.0) integrate with MRI systems, and what compatibility requirements must be met?
The UroNav (Version 2.0) integrates directly with MRI systems to offer real-time tracking, but it requires strict electromagnetic interference (EMI) compliance to ensure safe and accurate operation within the MRI environment. Users must verify compatibility with their specific MRI scanner model and follow manufacturer guidelines for calibration and setup to avoid interference or signal distortion.
What regulatory pathways does the UroNav (Version 2.0) follow, and which advisory committee oversees its classification?
The UroNav (Version 2.0) was cleared under the FDA 510(k) pathway (K153073) and is classified under product code LLZ, which falls under the Radiology Advisory Committee (RA) for review. It also complies with the Medical Device Directive (MDD) in its original market. The device was deemed substantially equivalent to a predicate, and its classification reflects its role in MRI-guided navigation systems.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K153073 | Class II | Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
Sources (3)
- FDA 510(k) K153073 24 fields · synced Sep 18, 2026
- FDA UDI 6e4f08fa-c910-40a6-9f24-94a811ab2870 35 fields · synced May 30, 2026
- EUDAMED b59f5696-6716-404e-b83d-f121285b2914 61 fields · synced Jul 9, 2026