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Amico Diagnostic Ophthalmoscope

Model DH-W35-CH-L · Amico Diagnostic Incorporated · DI 00697077000028

HLI — Ophthalmoscope, Ac-Powered · Class II · 21 CFR 886.1570

UDILibrary device dossier · generated 2026-09-12 · 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.

01112020-08: 0 reports for this device; peer average 1/device08
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0801
This device (reports/month)Average device in HLI (reports/device/month)

Regulatory clearances

  • K131939 SESE 2014-03-26 (k number procode)

Predicate lineage

K131939 — cites (transitively): K950461 (d1)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Amico Diagnostic Incorporated

  • VAI 2016-10-27 Amico Diagnostic Incorporated · 7 citations
  • VAI 2016-10-27 Amico Diagnostic Incorporated · 7 citations