This company has registrations in United States — 1 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 | K201933 | ImagenSPECT 3.0 | 2020-08-11 |
| US | K173547 | ImagenUniversal | 2018-01-12 |
| US | K152503 | ImagenSPECT | 2016-01-25 |