RetCam Envision

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203500

by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)

Identifiers

510(k) Number: K203500 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 RetCam Envision is an ophthalmic imaging system, a Class 2 device with product code HKI. It is used for general ophthalmic imaging, including retinal, corneal, and external imaging, as well as photodocumentation of pediatric ocular diseases.

The RetCam Envision is supplied as a single device and is intended for use in an ophthalmic setting. It has been cleared through the Traditional 510(k) pathway and has an FDA 510(k) clearance, K203500. The device is an AC-powered camera.

Frequently asked questions

What is the RetCam Envision used for?

The RetCam Envision is used for general ophthalmic imaging, including retinal, corneal, and external imaging, as well as photodocumentation of pediatric ocular diseases.

Is the RetCam Envision a single-use device?

The RetCam Envision is supplied as a single device, intended for use in an ophthalmic setting, but its single-use or reuse status is not specified.

What is the power source of the RetCam Envision?

The RetCam Envision is an AC-powered camera.

What regulatory pathway was used for the RetCam Envision?

The RetCam Envision has been cleared through the Traditional 510(k) pathway and has an FDA 510(k) clearance, K203500.

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: RetCam® Envision - ophthalmic imaging system - Natus Sensory, RetCam Envision by Natus Medical Incorporated DBA Excel-Tech Ltd ..., K203500 FDA 510 (k) - RetCam Envision, PDF 1-4 U.s. Food & Drug Adm in I Trat Ion

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K203500	Class II	Active

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Manufacturer

Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd (xltek)
FDA Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

Sources (1)

FDA 510(k) K203500 24 fields · synced Oct 1, 2026