Centervue Macular Integrity Assessment
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133758 FDA 510(k)
- FDA Product Code
- HLI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1570 FDA 510(k)
- Regulation Number
- 886.1570 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Centervue Macular Integrity Assessment is an Ac-Powered Ophthalmoscope designed to evaluate macular function. It measures macular sensitivity, fixation stability, and the locus of fixation while providing infrared retinal imaging. The device includes a reference database for quantitative comparison of macular sensitivity against normative data from healthy subjects.
This system is intended for use in clinical ophthalmic settings and is supplied as a reusable medical device. It has received FDA 510(k) clearance under the Ophthalmic advisory committee and is classified as a Class II device. The device requires proper calibration and maintenance in accordance with manufacturer guidelines to ensure accurate diagnostic results.
Frequently asked questions
What specific macular assessments does the Centervue Macular Integrity Assessment perform, and how does it compare results to healthy subjects?
The Centervue Macular Integrity Assessment evaluates macular sensitivity, fixation stability, and the precise location of fixation. It includes a built-in reference database to enable quantitative comparison of a patient’s macular sensitivity against normative data from healthy subjects, helping clinicians identify deviations from typical performance.
Is the device single-use or reusable, and what maintenance is required to ensure accurate diagnostic results?
The Centervue Macular Integrity Assessment is designed as a reusable medical device. To maintain accuracy, it requires proper calibration and regular maintenance as outlined in the manufacturer’s guidelines, ensuring reliable diagnostic performance over time.
What regulatory pathway was followed for FDA clearance, and which advisory committee was involved?
The device received FDA 510(k) clearance under the Ophthalmic Advisory Committee (OP) through a traditional review process, with a decision code of SESE (Substantially Equivalent). It is classified as a Class II device, indicating it poses moderate risk and requires specific regulatory oversight.
Does the device include imaging capabilities, and if so, what type of imaging does it provide?
Yes, the Centervue Macular Integrity Assessment provides infrared retinal imaging alongside its functional assessments. This allows clinicians to visually correlate structural details of the retina with the measured macular sensitivity and fixation stability.
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: PDF centervue - Food and Drug Administration, MAIA Macular Integrity Assessment System from CenterVue, Centervue S.P.A. FDA 510(k) Ophthalmic Products - Latest 2025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133758 | Class II | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
Sources (1)
- FDA 510(k) K133758 24 fields · synced Sep 19, 2026