510(k) K211817

Anterion by Heidelberg Engineering GmbH — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 5, 2021
Date Received: June 11, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tomography, Optical Coherence
Device Class: Class II
Regulation Number: 886.1570
Review Panel: OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

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K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
K223557 — SPECTRALIS HRA+OCT and variants (October 20, 2023)
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K181594 — Spectralis HRA+OCT and variants with OCT Angiography Module (September 13, 2018)

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K233933 — CIRRUS HD-OCT Model 6000 (May 17, 2024)
K233602 — P200TE (A10700) (May 9, 2024)
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