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ANTERION

Model Software V.1.5 US · Heidelberg Engineering GmbH · DI 04059237000952

OBO — Tomography, Optical Coherence · Class II · 21 CFR 886.1570

UDILibrary device dossier · generated 2026-09-15 · 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

  • K240924 SESE 2024-12-13 (k number procode)

Predicate lineage

K240924 — cites (transitively): K181534 (d1), K230897 (d1), K150977 (d2), K153416 (d2), K161194 (d2), K152311 (d2), K211817 (d2), K051789 (d3), K111157 (d3), K030719 (d3), K122418 (d3), K021333 (d3), K143275 (d3), K083291 (d4), K082891 (d4), K141068 (d4), K101861 (d5), K123464 (d5), K963333 (d6), K980295 (d6)

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