FDA applicant
Medical Intelligence Medizintechnik GmbH
FDA records 8 decisions for Medical Intelligence Medizintechnik GmbH (Schwabmuenchen, DE) from 2002 to 2015: 8 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and JAI (Couch, Radiation Therapy, Powered). Its devices cite 5 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medical Intelligence Medizintechnik GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
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