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Spectralis HRA + OCT and variants

by Heidelberg Engineering GmbH Germany 510(k)

510(k) K173648

Product code OBO

Overview

The Spectralis HRA + OCT is an ophthalmic device that combines Heidelberg Retina Angiography (HRA) with Optical Coherence Tomography (OCT) technology for diagnostic imaging of the eye. This device provides high-resolution images of retinal structures and vasculature, enabling detailed assessment of ocular conditions. The integration of these two imaging modalities allows for comprehensive evaluation of retinal morphology and function.

The device is supplied by Heidelberg Engineering GmbH and is intended for use in clinical ophthalmic settings. It is a Class II medical device cleared by the FDA through the 510(k) process (K173648) as substantially equivalent to predicate devices. The Spectralis HRA + OCT system is designed for multiple uses and requires appropriate storage conditions as specified by the manufacturer. The device includes various model numbers and configurations as indicated in the FDA registration data.

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 NumberK173648 Date30 Aug 2018ClearedStatusActive

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 America
  • Active
  • 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
OBO
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Other devices from Heidelberg Engineering GmbH

See all devices from Heidelberg Engineering GmbH →

Questions

  • What is the Spectralis HRA + OCT device used for?

    The Spectralis HRA + OCT is an ophthalmic device that combines Heidelberg Retina Angiography (HRA) with Optical Coherence Tomography (OCT) technology to provide high-resolution images of retinal structures and vasculature, enabling detailed assessment of ocular conditions.

  • How is the Spectralis HRA + OCT supplied and what are its storage requirements?

    The device is supplied by Heidelberg Engineering GmbH for use in clinical ophthalmic settings. It is designed for multiple uses and requires appropriate storage conditions as specified by the manufacturer to maintain optimal performance.

  • What is the regulatory status of the Spectralis HRA + OCT device?

    The Spectralis HRA + OCT is a Class II medical device cleared by the FDA through the 510(k) process (K173648) as substantially equivalent to predicate devices. It is intended for diagnostic imaging of the eye in clinical settings.

  • What models and configurations are available for the Spectralis HRA + OCT?

    The Spectralis HRA + OCT system includes various model numbers and configurations as indicated in the FDA registration data. These variants offer different options to meet specific clinical needs while maintaining the core functionality of combining angiography and OCT imaging technologies.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K173648 24 fields · synced 22 Oct 2026