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Huvitz Imaging System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K161829

by Huvitz Co., Ltd.

Identifiers

510(k) Number
K161829 FDA 510(k)
FDA Product Code
NFJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Huvitz Imaging System is a medical imaging device classified as an Image Management System for Ophthalmic Use, designed to capture, process, and store digital retinal images. It integrates diagnostic imaging capabilities to support ophthalmic evaluations, including fundus photography and related diagnostic imaging modalities.

This system is intended for use in radiology and ophthalmic settings, supplied as a reusable device with FDA 510(k) clearance and EU MDR compliance. It operates within Class II regulatory classification and is intended for professional medical environments, with no indication of MRI compatibility or single-use specifications. The device is authorized under the regulation number 892.2050 and is distributed by Huvitz Co., Ltd.

Frequently asked questions

What types of retinal imaging does the Huvitz Imaging System support, and where is it primarily used?

The Huvitz Imaging System is designed to capture and process digital retinal images, specifically supporting fundus photography and related ophthalmic diagnostic imaging modalities. It is intended for use in radiology and ophthalmic settings, making it suitable for professional medical environments where retinal evaluations are conducted.

Is the Huvitz Imaging System reusable or single-use, and how does this affect its maintenance?

The Huvitz Imaging System is explicitly described as a reusable device, meaning it is not intended for single-use. This classification implies that it requires proper cleaning, disinfection, and maintenance protocols to ensure consistent performance and compliance with regulatory standards.

What regulatory pathways has the Huvitz Imaging System followed, and what does this mean for its use in the U.S. and EU?

The Huvitz Imaging System has received FDA 510(k) clearance under the traditional review pathway, classified as Substantially Equivalent (SESE) to a predicate device, and is authorized under regulation number 892.2050. Additionally, it complies with the EU Medical Device Regulation (MDR), ensuring its use is authorized in both the U.S. and EU markets under these regulatory frameworks.

Does the Huvitz Imaging System have any compatibility restrictions, such as MRI use, that clinicians should be aware of?

The provided data does not mention MRI compatibility for the Huvitz Imaging System. Clinicians should confirm with the manufacturer whether the device or its components can be safely used in an MRI environment, as this information is not explicitly stated in the regulatory documentation.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Huvitz Co., Ltd.

Sources (2)

  • FDA 510(k) K161829 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026