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iExaminer System with Panoptic Plus

by Welch Allyn, Inc.

510(k) K223381

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223381↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223381 Date15 Mar 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HKI
Device Class
Class II
Regulation
21 CFR Part 886.1120
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The iExaminer System with Panoptic Plus is an ophthalmic camera system designed for capturing high-resolution retinal images. It integrates with a PanOptic Plus ophthalmoscope to enable digital imaging of the eye, facilitating remote consultation and diagnostic review by trained healthcare professionals.

This system is supplied as a reusable diagnostic tool, comprising the PanOptic Plus ophthalmoscope, SmartBracket, SmartClip, and the iExaminer application for mobile devices. It operates in clinical or school-based settings and requires a compatible smartphone with a case meeting specified guidelines. The device holds FDA 510(k) and MDR authorizations, classified as a Class II medical device under regulation 886.1120.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical settings is the iExaminer System with Panoptic Plus intended for use in?

    The iExaminer System with Panoptic Plus is designed for use in clinical settings as well as school-based environments. Its digital imaging capabilities support remote consultations and diagnostic reviews by trained healthcare professionals, making it versatile for both traditional healthcare facilities and non-traditional settings like schools.

  • Is the iExaminer System with Panoptic Plus reusable or single-use, and what components make up the system?

    The iExaminer System with Panoptic Plus is a reusable diagnostic tool. It consists of the PanOptic Plus ophthalmoscope, SmartBracket, SmartClip, and the iExaminer application for mobile devices. The system requires a compatible smartphone with a case that meets specified guidelines for operation.

  • What type of regulatory authorization does the iExaminer System with Panoptic Plus hold, and how is it classified?

    The iExaminer System with Panoptic Plus holds FDA 510(k) and MDR authorizations. It is classified as a Class II medical device under regulation 886.1120, indicating it has undergone substantial equivalence review by the FDA and meets EU medical device regulations.

  • How does the iExaminer System with Panoptic Plus integrate with other devices, and what is required for its operation?

    The iExaminer System integrates with the PanOptic Plus ophthalmoscope to capture high-resolution retinal images. To operate, it requires a compatible smartphone with a case that adheres to the manufacturer’s guidelines, ensuring proper functionality for digital imaging.

  • What is the primary purpose of the SmartBracket and SmartClip in the iExaminer System?

    The SmartBracket and SmartClip are components of the iExaminer System designed to securely attach and stabilize the PanOptic Plus ophthalmoscope to the smartphone case. This setup ensures proper alignment and imaging quality for capturing high-resolution retinal images.