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mMR Head/Neck coil set

Model 10185547 · Siemens Healthcare GmbH · DI 04056869014753

OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance · Class II · 21 CFR 892.1200

UDILibrary device dossier · generated 2026-09-07 · 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.

01112026-04: 0 reports for this device; peer average 1/device04
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2026-0401
This device (reports/month)Average device in OUO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K133226 — cites (transitively): K103429 (d1), K123737 (d1), K123938 (d1), K081453 (d2), K082427 (d2), K113448 (d2), K121434 (d2), K091114 (d3), K103274 (d3), K053042 (d4) — cited as predicate by K142098, K163234

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Siemens Healthcare GmbH

  • NAI 2014-09-25 Siemens AG/Siemens Healthcare GmbH · 0 citations
  • VAI 2011-06-09 Siemens Healthcare GmbH · 1 citations
  • NAI 2010-09-14 Siemens AG/Siemens Healthcare GmbH · 0 citations