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ANTERION

Model 88036 · Heidelberg Engineering GmbH · DI 04059237000938

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.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1
2023-04	0	2
2025-04	0	2

This device (reports/month)Average device in OBO (reports/device/month)

Regulatory clearances

K240924 SESE 2024-12-13 (k number procode)
K230897 SESE 2023-10-11 (k number procode)

Predicate lineage

K230897 — cites (transitively): K150977 (d1), K152311 (d1), K211817 (d1), K051789 (d2), K111157 (d2), K030719 (d2), K122418 (d2), K083291 (d3) — cited as predicate by K240924

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