510(k) K231328 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
LUX-Dx II (M302); LUX-Dx II+ (M312)
| Applicant | Boston Scientific Corp, St Paul MN, US |
| Decision | Substantially Equivalent, Aug 19, 2023 |
| Received | May 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2026 | Boston Scientific Corporation LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8) Open, Classified |
MXD | None listed |
| Sep 2, 2026 | Boston Scientific Corporation LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7) Open, Classified |
MXD | None listed |
| Sep 2, 2026 | Boston Scientific Corporation LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7) Open, Classified |
MXD | None listed |
| May 1, 2026 | Boston Scientific Corporation LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 Open, Classified |
MXD | None listed |
| May 1, 2026 | Boston Scientific Corporation LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Vers Open, Classified |
MXD | None listed |
| Oct 25, 2024 | Boston Scientific Corporation Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application. Open, Classified |
MXD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.