FDA applicant
Siemens AG Medical Solutions
FDA records 31 decisions for Siemens AG Medical Solutions (Erlangen, DE) from 2003 to 2015: 31 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and JAK (System, X-Ray, Tomography, Computed). Its devices cite 61 predicates, 27 of them its own earlier devices. 48 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens AG Medical Solutions’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
4in 2017
Class I Class II/III not classified
Planning a device like Siemens AG Medical Solutions’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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