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FDA 510(k)

Anterion

K-Number: K230897 · 2023-10-11

ApplicantHeidelberg Engineering GmbH
Decision Date2023-10-11
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Anterion is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2023-10-11 under 510(k) number K230897. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anterion?

Anterion is a medical device that received FDA 510(k) clearance on 2023-10-11. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K230897.

When did Anterion receive FDA 510(k) clearance?

Anterion received FDA 510(k) clearance on 2023-10-11, under 510(k) number K230897.

Who is the listed applicant for Anterion?

The FDA 510(k) record lists Heidelberg Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anterion?

The FDA product code for Anterion is OBO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06657716Heidelberg Engineering ANTERION Software Comparison StudyACTIVE_NOT_RECRUITINGNCT07338461High Resolution Imaging OCT StudyRECRUITING

Other records listing Heidelberg Engineering GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleK250868SPECTRALIS HRA+OCT and variantsK240924AnterionK241163SPECTRALIS with Flex ModuleK240221SPECTRALIS HRA+OCT and variantsK223557SPECTRALIS HRA+OCT and variants

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Related Devices (Code: OBO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbHK241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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