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Avanti

Model RTVue XR100-2 · OPTOVUE, INC. · DI 00858848006025

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

OBO — Tomography, Optical Coherence · 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.

11222019-01: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2/device01080404
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2020-0801
2023-0402
2025-0402
This device (reports/month)Average device in HLI, OBO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K153080 — cites (transitively): K120238 (d1), K150977 (d1), K101505 (d2), K051789 (d2), K111157 (d2), K062552 (d3), K071250 (d3), K083291 (d3) — cited as predicate by K180660, K181594, K182942, K213265

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

Manufacturer compliance record — OPTOVUE, INC.

  • Warning Letter 2010-06-11 Optovue, Inc.
  • Warning Letter 2010-06-11 Optovue, Inc.
  • NAI 2017-03-20 Optovue, Inc. · 0 citations
  • NAI 2017-03-20 Optovue, Inc. · 0 citations
  • NAI 2016-04-14 Optovue, Inc. · 0 citations
  • NAI 2016-04-14 Optovue, Inc. · 0 citations
  • VAI 2013-11-15 Optovue, Inc. · 3 citations
  • VAI 2013-11-15 Optovue, Inc. · 3 citations
  • OAI 2012-09-14 Optovue, Inc. · 2 citations
  • OAI 2012-09-14 Optovue, Inc. · 2 citations
  • VAI 2011-04-07 Optovue, Inc. · 6 citations
  • VAI 2011-04-07 Optovue, Inc. · 6 citations
  • OAI 2010-01-08 Optovue, Inc. · 7 citations
  • OAI 2010-01-08 Optovue, Inc. · 7 citations