FDA applicant
Siemens Healthcare GmbH
FDA records 32 decisions for Siemens Healthcare GmbH (Erlangen, DE) from 2016 to 2026: 32 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 131 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 15 of them its own earlier devices. 3 recalls are linked to its devices, 2 Class I.
FDA’s records also spell it “Siemens Healthcare”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Siemens Healthcare GmbH’s devices, and how often a recall has named them.
FDA decisions per year
6in 2025
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Siemens Healthcare GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report