← Back to catalogue

Huvitz Imaging System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191615

by Huvitz Co., Ltd.

Identifiers

510(k) Number
K191615 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 tailored for ophthalmic applications, enabling clinicians to assess retinal conditions with high-resolution imaging technology.

This system is intended for use in radiology and ophthalmology settings, supplied as a reusable, non-sterile device. It operates under FDA 510(k) clearance and EU MDR compliance, with a classification as a Class II medical device. The system supports multiple imaging modalities and is regulated under the U.S. regulation number 892.2050, ensuring adherence to strict quality and safety standards for diagnostic imaging.

Frequently asked questions

What clinical settings is the Huvitz Imaging System designed for and how does it support ophthalmic diagnostics?

The Huvitz Imaging System is specifically designed for use in radiology and ophthalmology settings. It integrates diagnostic imaging capabilities tailored for ophthalmic applications, allowing clinicians to capture, process, and store high-resolution digital retinal images. This enables detailed assessment of retinal conditions, enhancing diagnostic accuracy and workflow efficiency in specialized eye care environments.

Is the Huvitz Imaging System reusable or single-use, and what does this mean for maintenance and infection control?

The Huvitz Imaging System is supplied as a reusable, non-sterile device. This means it is intended for repeated use across multiple patients, requiring proper cleaning, disinfection, and maintenance procedures to ensure safety and functionality. Clinicians must follow manufacturer guidelines for reprocessing to minimize infection risks and maintain imaging quality.

What regulatory pathways does the Huvitz Imaging System follow in the U.S. and EU, and how does this impact its use?

The Huvitz Imaging System is cleared under the FDA’s 510(k) pathway (K191615) as a Class II device, regulated under U.S. regulation number 892.2050, and complies with the EU Medical Device Regulation (MDR). This classification ensures it meets stringent safety and performance standards for diagnostic imaging, allowing its use in clinical settings where high-resolution retinal imaging is required, with adherence to both U.S. and EU regulatory requirements.

Does the Huvitz Imaging System support multiple imaging modalities, and if so, how might this benefit ophthalmic practices?

Yes, the Huvitz Imaging System is designed to support multiple imaging modalities for ophthalmic use. This versatility allows clinicians to capture a broader range of retinal images, including different diagnostic views or conditions, within a single system. This can streamline workflows, reduce equipment needs, and improve diagnostic flexibility for comprehensive retinal assessments.

How should the Huvitz Imaging System be stored, and are there any specific environmental conditions that must be met?

While the exact storage instructions are not detailed in the provided data, as a reusable, non-sterile imaging system, the Huvitz Imaging System should be stored in a clean, dry environment protected from dust, moisture, and extreme temperatures. Proper storage ensures longevity and maintains the system’s performance for high-resolution retinal imaging. Always refer to the manufacturer’s instructions for precise guidelines.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Huvitz Co., Ltd.

Sources (2)

  • FDA 510(k) K191615 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026