NVision VLE Imaging System NVision VLE Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121195 FDA 510(k)
- FDA Product Code
- NQQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NVision VLE Imaging System NVision VLE Catheter is an Optical Coherence Tomography (OCT) system designed for high-resolution, cross-sectional imaging of human tissue microstructure. It provides real-time, two-dimensional visualization of tissue at depths up to 3 millimeters with a resolution of 7 microns, enabling detailed evaluation of esophageal and other tissue structures during procedures.
This device is intended for use in radiology settings and is supplied as a reusable system with associated single-use catheters. It has received FDA 510(k) clearance under Special Review (K121195) and is classified as a Class II medical device (regulation number 892.1560). The system operates in non-MRI environments and requires proper storage and handling as specified by the manufacturer.
Frequently asked questions
What types of tissues can the NVision VLE Imaging System be used to visualize, and how detailed are the images produced?
The NVision VLE Imaging System is specifically designed for high-resolution, cross-sectional imaging of human tissue microstructure, particularly focused on esophageal structures. It provides real-time, two-dimensional visualization with a resolution of 7 microns, allowing for detailed evaluation of tissue layers at depths up to 3 millimeters. This level of detail helps clinicians assess tissue integrity and abnormalities during procedures.
Is the NVision VLE Imaging System reusable, and how are the catheters supplied?
The NVision VLE Imaging System itself is a reusable device, as indicated in the product description. However, the associated catheters are single-use components, meaning each catheter is intended for one procedure and must be replaced after use to ensure sterility and safety.
What kind of environment is the NVision VLE Imaging System intended for, and are there any special storage or handling requirements?
The NVision VLE Imaging System is designed for use in radiology settings and is explicitly noted to operate in non-MRI environments. Proper storage and handling instructions are provided by the manufacturer, Ninepoint Medical, Inc., to maintain device performance and sterility, particularly since the system includes single-use catheters.
How was the regulatory pathway for the NVision VLE Imaging System determined, and what does this mean for its use?
The NVision VLE Imaging System received FDA 510(k) clearance under Special Review, classified as a Class II medical device under regulation number 892.1560. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the market while adhering to stricter review scrutiny. Clinically, this classification ensures it meets established safety and performance standards for radiology imaging systems.
What specialties or procedural settings would benefit most from using the NVision VLE Imaging System?
The NVision VLE Imaging System is categorized under Radiology and is intended for use in settings where detailed visualization of tissue microstructure is critical. While primarily designed for esophageal imaging, its high-resolution capabilities make it particularly useful in procedures requiring precise evaluation of soft tissue structures, such as endoscopy or interventional radiology.
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: NvisionVLE Imaging System - NinePoint Medical, Inc., NVision Quantum Technologies GmbH, Home :: NinePoint Medical, Inc., NVision Quantum Technologies | LinkedIn
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121195 | Class II | Active |
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Manufacturer
- Manufacturer
- Ninepoint Medical, Inc.
Sources (1)
- FDA 510(k) K121195 24 fields · synced Oct 6, 2026