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ACTEON
Model SYSTEME PSPIX WIN MAC · SOPRO · DI M430S70200111
MUH — System, X-Ray, Extraoral Source, Digital · Class II · 21 CFR 872.1800
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2023-08 | 0 | 2 |
| 2023-10 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-04 | 0 | 1 |
Regulatory clearances
- K151053 SESE 2015-07-31 (k number procode)
Manufacturer compliance record — SOPRO
- VAI 2022-07-21 SOPRO · 3 citations