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ApolloVue S100 Image System

by Apollo Medical Optics, Ltd. Taiwan 510(k)

510(k) K201552 Product code NQQ

Overview

The ApolloVue S100 Image System is an optical coherence tomography (OCT) imaging system used for radiology applications. It provides detailed imaging capabilities for medical diagnostic purposes.

The ApolloVue S100 Image System is supplied by Apollo Medical Optics, Ltd. and has received FDA 510(k) clearance as a Class II device. It is regulated under product code NQQ and regulation number 892.1560.

Summary written by AI from registry data, 23 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically 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.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201552 Date2 Sep 2020ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
NQQ
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Apollo Medical Optics, Ltd.

Questions

  • What is the ApolloVue S100 Image System used for?

    The ApolloVue S100 Image System is an optical coherence tomography (OCT) imaging system designed for radiology applications, providing detailed imaging capabilities for medical diagnostic purposes.

  • How is the ApolloVue S100 Image System supplied?

    The ApolloVue S100 Image System is supplied by Apollo Medical Optics, Ltd., a medical device manufacturer based in Taipei City, Taiwan.

  • What is the regulatory status of the ApolloVue S100 Image System?

    The ApolloVue S100 Image System has received FDA 510(k) clearance as a Class II device, regulated under product code NQQ and regulation number 892.1560.

  • What are the specifications of the ApolloVue S100 Image System?

    The ApolloVue S100 Image System is an optical coherence tomography imaging system with detailed imaging capabilities for medical diagnostic purposes. It has been determined to be substantially equivalent to predicate devices.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K201552 24 fields · synced 22 Oct 2026