This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia — 7 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| EU | 04250802900213 | — | Class IIb |
| EU | 04250802900374 | Leonardo DR Go | Class IIb |
| EU | 04250802900367 | Mobiles Röntgenstativ Amadeo mini | Class IIb |
| EU | 04250802900275 | Amadeo R-DR | Class IIb |
| UK | 40866 | dicomPACS MobileView | Class IIa |
| UK | 40866 | ORCA | Class IIa |
| UK | 58473 | dicomPACS | Class IIa |
| US | K182317 | AMADEO M-DR mini, AMADEO M-AX mini | 2018-09-24 |
| US | K141440 | DICOMPACS DX-R WITH FLAT PANEL | 2014-08-29 |
| US | K131211 | DICOMPACS DX-R WITH FLAT PANEL | 2013-11-05 |
| BR | 81127640003 | Sistema de Digitalização e Processamento de Imagem Radiográfica DR | Class II |