Identifiers
- 510(k) Number
- K162466 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 LuminScan Imaging System is an Optical Coherence Tomography (OCT) device designed for high-resolution, cross-sectional imaging of biological tissues. It operates using near-infrared light to capture detailed internal images, primarily for diagnostic applications in radiology, including ophthalmology and dermatology. The system enables real-time visualization of structural layers, aiding in the assessment of conditions such as retinal disorders or skin pathologies.
This device is supplied as a Class II medical system and has received FDA 510(k) clearance under K-number K162466, classified under regulation number 892.1560. It is intended for use in radiology settings, with no explicit mention of sterility or single-use/reusable status in the regulatory data. The system’s imaging capabilities are governed by the manufacturer’s specifications, and its use adheres to standard radiology protocols. No additional regulatory markings or MRI safety classifications are provided in the available data.
Frequently asked questions
What is the LuminScan Imaging System used for?
The LuminScan Imaging System is designed for high-resolution, cross-sectional imaging of biological tissues using near-infrared light. It is primarily intended for diagnostic applications in radiology, particularly in ophthalmology and dermatology. This allows clinicians to visualize structural layers in real-time, facilitating the assessment of conditions such as retinal disorders or skin pathologies.
How is the LuminScan Imaging System supplied and what is its regulatory status?
The LuminScan Imaging System is supplied as a Class II medical device and has received FDA 510(k) clearance under K-number K162466. It is classified under regulation number 892.1560 and is intended for use in radiology settings. The regulatory data does not specify whether the system is single-use or reusable, so its use must adhere to standard radiology protocols and manufacturer guidelines.
Does the LuminScan Imaging System have any specific sterility requirements?
The available regulatory data for the LuminScan Imaging System does not explicitly mention sterility or single-use/reusable status. As a result, the sterility and handling requirements would depend on the manufacturer’s specifications and standard radiology practices for imaging systems. Always follow the manufacturer’s instructions for proper use and maintenance.
What types of tissues or conditions can the LuminScan Imaging System help diagnose?
The LuminScan Imaging System is optimized for capturing detailed images of biological tissues, particularly in ophthalmology for retinal disorders and in dermatology for skin pathologies. Its near-infrared light technology enables real-time visualization of internal tissue structures, aiding in the diagnosis and assessment of conditions that require detailed cross-sectional imaging.
Are there any specific safety considerations or regulatory markings for the LuminScan Imaging System?
The regulatory data for the LuminScan Imaging System does not provide explicit safety markings such as MRI compatibility or additional regulatory warnings beyond its FDA 510(k) clearance. As with any medical imaging device, its use should follow standard radiology protocols to ensure patient safety. Always refer to the manufacturer’s guidelines for proper operation and maintenance.
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: LuminScan (TM) Imaging System (K162466) — FDA 510(k) | Innolitics, Micro-Tech LuminScan (TM) Imaging - allmed.wiki, LuminScan (TM) Imaging System — FDA 510(k) K162466 | MedTracker, PDF K162466 LuminScan (TM) Imaging System - 510kdatabase.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162466 | Class II | Active |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA 510(k) K162466 24 fields · synced Oct 1, 2026