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AXIS Image Management System

Model Ver 5 · SONOMED, INC. · DI 00896100002002

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.

01112019-01: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device0111
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2022-1101
This device (reports/month)Average device in NFJ (reports/device/month)

Regulatory clearances

  • K171098 SESE 2017-05-02 (k number procode)

Predicate lineage

K171098 — cited as predicate by K170798, K200385

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

Manufacturer compliance record — SONOMED, INC.

  • VAI 2022-07-14 Sonomed, Inc. · 2 citations
  • VAI 2022-07-14 Sonomed, Inc. · 2 citations
  • VAI 2016-04-15 Sonomed, Inc. · 1 citations
  • VAI 2016-04-15 Sonomed, Inc. · 1 citations
  • VAI 2014-08-11 Sonomed, Inc. · 2 citations
  • VAI 2014-08-11 Sonomed, Inc. · 2 citations
  • VAI 2011-02-10 Sonomed, Inc. · 3 citations
  • VAI 2011-02-10 Sonomed, Inc. · 3 citations