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ANTERION

Model 88036 · Heidelberg Engineering GmbH · DI 04059237000617

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.

11222019-01: 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/device010404
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2023-0402
2025-0402
This device (reports/month)Average device in OBO (reports/device/month)

Regulatory clearances

  • K211817 SESE 2021-11-05 (k number procode)

Predicate lineage

K211817 — cites (transitively): K051789 (d1), K150977 (d1), K111157 (d2), K083291 (d3) — cited as predicate by K230897

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

Manufacturer compliance record — Heidelberg Engineering GmbH

  • NAI 2017-01-20 Heidelberg Engineering · 0 citations
  • VAI 2011-02-03 Heidelberg Engineering GmbH · 1 citations
  • VAI 2011-02-03 Heidelberg Engineering GmbH · 1 citations