NvisionVLE Imaging System, NvisionVLE Optical Probe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182261 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
- SESU FDA 510(k)
The NvisionVLE Imaging System is an optical coherence tomography (OCT) imaging device that includes the NvisionVLE Optical Probe. This system is designed for medical imaging purposes in the field of radiology.
The device is supplied by Ninepoint Medical, Inc. and has received FDA 510(k) clearance with product code NQQ. It is classified as a class II medical device and is regulated under regulation number 892.1560. The device is intended for use in radiology settings, though specific details on sterility, single-use or reusable status, MRI safety, and storage are not provided in the data.
Frequently asked questions
What is the NvisionVLE Imaging System used for?
The NvisionVLE Imaging System is an optical coherence tomography (OCT) imaging device designed for medical imaging purposes in the field of radiology. It includes the NvisionVLE Optical Probe to assist in imaging procedures.
What is the regulatory status of the NvisionVLE Imaging System?
The NvisionVLE Imaging System has received FDA 510(k) clearance with product code NQQ. It is classified as a class II medical device and is regulated under regulation number 892.1560.
Who manufactures the NvisionVLE Imaging System?
The NvisionVLE Imaging System is manufactured by Ninepoint Medical, Inc., located in Bedford, MA. The company developed this OCT imaging device for use in radiology settings.
Is the NvisionVLE Optical Probe single-use or reusable?
The device data does not specify whether the NvisionVLE Optical Probe is single-use or reusable. Additional information regarding sterility, reuse status, and storage requirements would need to be obtained directly from the manufacturer.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182261 | Class II | Active |
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Manufacturer
- Manufacturer
- Ninepoint Medical, Inc.
Sources (1)
- FDA 510(k) K182261 24 fields · synced Oct 6, 2026