This company has registrations in United States, Canada — 2 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 |
|---|---|---|---|
| US | K123408 | ERGO IMAGING SYSTEM | 2013-01-15 |
| US | K100838 | ERGO IMAGING SYSTEM | 2010-04-23 |
| US | K083649 | CARDIUS 3 X-ACT | 2009-03-09 |
| CA | 68108 | 2020 SPECT IMAGING SYSTEM | Class II |