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Fundus Autoimager

by Visual Pathways, Inc.

510(k) K020888

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK020888 Date7 Nov 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 23 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 Fundus Autoimager is an AC-powered ophthalmic camera designed to automate the process of obtaining digital, color, stereo images of the ocular fundus. It functions as an imaging instrument for clinical ophthalmic use.

This device has received FDA 510(k) clearance. It is manufactured by Visual Pathways, Inc. and is categorized under regulation number 886.1120.

Questions

AI-generated answers, 23 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 is the primary function of the Fundus Autoimager?

    The Fundus Autoimager is an AC-powered ophthalmic camera designed for clinical use to automate the process of obtaining digital, color, and stereo images of the ocular fundus.

  • Has this device received regulatory clearance?

    Yes, the Fundus Autoimager has received FDA 510(k) clearance under K-number K020888.

  • Who is the manufacturer of this ophthalmic camera?

    The Fundus Autoimager is manufactured by Visual Pathways, Inc., located in Prescott, Arizona.