Anterion Software V. 1.5

Full name

ANTERION Software

Model / Reference

ANTERION Software V. 1.5, 4001670

Primary DI / UDI-DI

04059237000907

Basic UDI-DI

4059237ANTERION_SWZ8

Direct Marketing DI

04059237000907

EMDN Code

Z12120192 Ophtalmology assessments and diagnosis instruments - medical device software

Device Class

Class IIb

Special Device Type

Software

Market of Registration

Germany

EUDAMED SRN

DE-MF-000008127

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  Class II

  FDA 510(k) K261019 Active Cleared 11 Sep 2026

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See all devices from Heidelberg Engineering GmbH →

• What clinical applications does the ANTERION Software support in ophthalmology?

  The ANTERION Software V. 1.5 specializes in anterior segment imaging using Optical Coherence Tomography (OCT) to provide detailed visualization and measurements of corneal topography, anterior chamber dimensions, lens structure, and axial length. These capabilities support comprehensive ocular assessments, including corneal tomography, biometry, and intraocular lens (IOL) calculations, making it useful for surgical planning and routine ophthalmic evaluations.

• Is the ANTERION Software reusable or single-use, and what does that mean for clinical workflows?

  The ANTERION Software is designed for single-use in clinical settings, meaning each installation or session is intended for one patient evaluation. Since it is a non-sterile, non-reusable digital platform, there is no need for reprocessing or sterilization between uses, simplifying workflows and reducing administrative burdens. Clinicians can rely on consistent performance without concerns about contamination or degradation over multiple uses.

• How is the ANTERION Software supplied, and are there any special handling requirements?

  The ANTERION Software is supplied as a non-sterile digital platform and does not require physical reprocessing or sterilization. It operates independently of hardware sterilization constraints, meaning it can be used directly after installation without additional preparation. However, since it is a software-based solution, ensure the underlying hardware (e.g., OCT scanner) meets the manufacturer’s operational and environmental requirements, such as temperature and humidity controls for optimal performance.

• What regulatory pathways does the ANTERION Software follow, and how does that affect its use?

  The ANTERION Software has been authorized through FDA 510K clearance and MDR compliance, confirming it meets regulatory standards for diagnostic imaging devices in the U.S. and EU markets. This classification ensures it adheres to safety and performance requirements for optical coherence tomography systems, particularly for anterior segment imaging. Clinicians can rely on its regulatory backing for use in ophthalmic practices, surgical planning, and biometry assessments without additional scrutiny beyond standard software updates or hardware compatibility checks.

• Does the ANTERION Software have any restrictions on use with other medical devices or imaging modalities?

  The ANTERION Software operates as a standalone diagnostic tool and does not have MRI restrictions, meaning it can be used in environments where MRI-compatible equipment is present. However, its functionality depends on integration with compatible OCT hardware (e.g., Heidelberg Engineering’s scanning systems). Always verify compatibility with the specific hardware model and follow the manufacturer’s guidelines for optimal performance and data accuracy, particularly when combining it with other imaging modalities or devices in clinical workflows.