Axilum Robotics
Model TMS-Explorer-1 · AXILUM ROBOTICS · DI 03701354630116
QFF — Electromechanical Arm For A Transcranial Magnetic Stimulation System · Class II · 21 CFR 882.5805
UDILibrary device dossier · generated 2026-09-16 · 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.
No dated reports to chart.
Regulatory clearances
- K182768 SESE 2019-02-17 (k number procode)
Predicate lineage
K182768 — cites (transitively): K150641 (d1), K151511 (d1), K061645 (d2), K071821 (d2), K083538 (d2), K091940 (d2), K133408 (d2), K101791 (d2), K101797 (d2), K133444 (d2), K926516 (d3), K944547 (d3), K001801 (d3), K023651 (d3), K092239 (d3), K991081 (d3), K002906 (d3), K042777 (d3), K060245 (d3), K061053 (d3), K130233 (d3), K050438 (d3) — cited as predicate by K252358, K253098
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — AXILUM ROBOTICS
- VAI 2024-11-06 AXILUM ROBOTICS SAS · 5 citations