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3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1

Model 3D OCT-1 · TOPCON CORPORATION · DI 04562123288322

HKI — Camera, Ophthalmic, Ac-Powered · Class II · 21 CFR 886.1120

OBO — Tomography, Optical Coherence · Class II · 21 CFR 886.1570

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12342019-01: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 4/device0112020405040704
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2021-1201
2022-0201
2023-0402
2023-0501
2025-0402
2025-0703
2026-0404
This device (reports/month)Average device in HKI, OBO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — TOPCON CORPORATION

  • Warning Letter 2011-10-12 Topcon Corporation
  • NAI 2016-03-16 Topcon Corporation · 0 citations