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AL-Scan Viewer for NAVIS-EX
Model 1.3 · NIDEK CO.,LTD. · DI 04987669200773
NFJ — System, Image Management, Ophthalmic · Class II · 21 CFR 892.2050
UDILibrary device dossier · generated 2026-09-14 · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2022-11 | 0 | 1 |
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — NIDEK CO.,LTD.
- Warning Letter 2014-08-08 Nidek, Inc.
- Warning Letter 2014-08-08 Nidek, Inc.
- Warning Letter 2013-09-24 NIDEK Co., Ltd.
- Warning Letter 2013-09-24 NIDEK Co., Ltd.
- NAI 2019-01-24 Nidek, Inc. · 0 citations
- NAI 2019-01-24 Nidek, Inc. · 0 citations
- NAI 2017-03-31 Nidek, Inc. · 0 citations
- NAI 2017-03-31 Nidek, Inc. · 0 citations
- NAI 2016-08-10 Nidek, Inc. · 0 citations
- NAI 2016-08-10 Nidek, Inc. · 0 citations
- VAI 2015-06-10 Nidek, Inc. · 1 citations
- VAI 2015-06-10 Nidek, Inc. · 1 citations
- VAI 2014-07-31 NIDEK Co., Ltd. · 6 citations
- VAI 2014-07-31 NIDEK Co., Ltd. · 6 citations
- OAI 2014-04-14 Nidek, Inc. · 10 citations
- OAI 2014-04-14 Nidek, Inc. · 10 citations
- VAI 2013-07-30 Nidek, Inc. · 7 citations
- VAI 2013-07-30 Nidek, Inc. · 7 citations
- VAI 2012-03-07 Nidek, Inc. · 3 citations
- VAI 2012-03-07 Nidek, Inc. · 3 citations
- NAI 2010-02-18 NIDEK Co., Ltd. · 0 citations
- NAI 2010-02-18 NIDEK Co., Ltd. · 0 citations