Identifiers
- 510(k) Number
- K043222 FDA 510(k)
- FDA Product Code
- HKI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1120 FDA 510(k)
- Regulation Number
- 886.1120 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Visucam C Digital Camera is an ophthalmic device classified as a camera, designed for capturing high-resolution digital images of the retina and surrounding ocular structures. It is an ac-powered, non-invasive tool used primarily in clinical settings to document retinal conditions such as glaucoma, diabetic retinopathy, and age-related macular degeneration (AMD). The device leverages advanced imaging technology to provide detailed visualizations essential for diagnostic and monitoring purposes in ophthalmology.
This device is supplied as a reusable medical instrument and is intended for use in clinical environments such as ophthalmology clinics or hospitals. It operates under standard electrical power and does not require MRI compatibility considerations. The Visucam C has received FDA 510K clearance under the Traditional pathway, with a classification as a Class II device. Storage and handling follow standard sterile or non-sterile medical device protocols, as dictated by clinical protocols and manufacturer guidelines.
Frequently asked questions
What is the Visucam C Digital Camera used for in clinical settings?
The Visucam C Digital Camera is designed for capturing high-resolution digital images of the retina and surrounding ocular structures. It is primarily used in ophthalmology to document and monitor retinal conditions such as glaucoma, diabetic retinopathy, and age-related macular degeneration (AMD). The detailed visualizations it provides are essential for accurate diagnosis and ongoing patient management.
Is the Visucam C Digital Camera reusable or single-use?
The Visucam C Digital Camera is supplied as a reusable medical instrument. It is intended for use in clinical environments like ophthalmology clinics or hospitals, where it undergoes routine maintenance and cleaning as per manufacturer guidelines to ensure reliability and sterility.
How is the Visucam C Digital Camera powered and does it require MRI compatibility?
The Visucam C operates using standard electrical power (ac-powered) and does not require MRI compatibility. This means it can be safely used in non-MRI environments without interference or safety concerns related to magnetic fields.
What storage and handling protocols should be followed for the Visucam C?
Storage and handling of the Visucam C follow standard protocols for reusable medical devices, as outlined by clinical protocols and the manufacturer’s guidelines. While the device itself is not sterile, it must be cleaned and maintained according to best practices to prevent contamination and ensure optimal performance.
What regulatory pathway was used for the FDA clearance of the Visucam C?
The Visucam C received FDA 510K clearance under the Traditional pathway, classified as a Class II device. This pathway involves demonstrating that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for its intended use.
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: ZEISS VISUCAM C USER MANUAL Pdf Download | ManualsLib, VISUCAM 224/524 Fundus Imaging Brochure EN - med-shop.zeiss.com, ZEISS Retinal Cameras | ZEISS Medical Technology, Carl Zeiss Meditec AG VISUCAM 224 VISUCAM 224
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043222 | Class II | Active |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
- FDA Applicant
- Carl Zeiss Meditec, AG
Sources (1)
- FDA 510(k) K043222 24 fields · synced Oct 5, 2026