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510(k) K201252

Spectralis HRA+OCT and variants by Heidelberg Engineering GmbH — Product Code OBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2020
Date Received
May 11, 2020
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)
  • K230897 — Anterion (October 11, 2023)
  • K211817 — Anterion (November 5, 2021)
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  • K182569 — Spectralis HRA+OCT and variants with High Magnification Module (October 18, 2018)
  • K181594 — Spectralis HRA+OCT and variants with OCT Angiography Module (September 13, 2018)

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  • K240924 — Anterion (December 13, 2024)
  • K241163 — SPECTRALIS with Flex Module (October 11, 2024)
  • K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
  • K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
  • K233933 — CIRRUS™ HD-OCT Model 6000 (May 17, 2024)
  • K233602 — P200TE (A10700) (May 9, 2024)
  • K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (April 10, 2024)