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 | K010772 | ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM | 2001-08-23 |
| US | K955251 | OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM | 1996-04-12 |