Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K243432 FDA 510(k)
- FDA Product Code
- OWB FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vascular Navigation PAD 2.0 is a navigation software system designed for interventional fluoroscopic X-ray procedures, specifically within the field of radiology. It integrates with image-intensified fluoroscopic systems to assist in vascular navigation, enhancing precision during complex interventions such as endovascular treatments.
This device is supplied as a software solution, intended for use in sterile or semi-sterile environments where fluoroscopy is performed. It operates as a reusable system, compatible with MRI-safe settings as defined by its regulatory classification under 21 CFR 892.1650 (Class II, Product Code OWB). Authorized under FDA 510K and MDR, it is regulated for interventional radiology applications and requires adherence to manufacturer-specific installation and maintenance protocols.
Frequently asked questions
What types of interventional procedures is the Vascular Navigation PAD 2.0 designed to assist with, and how does it integrate with existing equipment?
The Vascular Navigation PAD 2.0 is specifically designed to assist in endovascular treatments during interventional fluoroscopic X-ray procedures, particularly in radiology. It integrates directly with image-intensified fluoroscopic systems to enhance precision by providing real-time navigation support. This software-based solution is meant to be used in sterile or semi-sterile environments where fluoroscopy is performed, ensuring compatibility with existing fluoroscopic setups without requiring additional hardware.
Is the Vascular Navigation PAD 2.0 a single-use or reusable device, and what maintenance requirements should I be aware of?
The Vascular Navigation PAD 2.0 is a reusable software system, meaning it is not disposable and can be used across multiple procedures. However, it requires adherence to manufacturer-specific installation and maintenance protocols to ensure optimal performance and compliance with regulatory standards. These protocols likely include software updates, system checks, and calibration to maintain accuracy and reliability.
Does the Vascular Navigation PAD 2.0 have any compatibility restrictions, such as MRI safety or specific fluoroscopic system requirements?
Yes, the Vascular Navigation PAD 2.0 is compatible with MRI-safe settings as defined under 21 CFR 892.1650 (Class II, Product Code OWB). This classification ensures it can be used in environments where MRI compatibility is a concern. However, it is not a standalone device—it must be integrated with image-intensified fluoroscopic systems for use, so compatibility depends on the specific fluoroscopic equipment in your facility.
How is the regulatory status of the Vascular Navigation PAD 2.0 determined, and what does that mean for my facility?
The Vascular Navigation PAD 2.0 holds FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for interventional radiology applications. This means your facility must follow the manufacturer’s guidelines for proper installation, training, and maintenance to ensure compliance with these regulatory pathways. The clearance also indicates it is substantially equivalent to predicate devices, as noted in the submission, but does not imply any specific clinical indication—only that it is suitable for use in fluoroscopic-guided vascular procedures.
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: Vascular Navigation PAD 2.0; Navigation Software Vascular PAD (K243432 ..., Vascular Navigation PAD 2.0; Navigation Software… - FDA.report, Brainlab Vascular Navigation Pad 2.0; Navigation Software…
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243432 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (2)
- FDA 510(k) K243432 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026