This company has registrations in United States, Canada, Taiwan, Australia, Hong Kong — 5 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 | K241069 | iLoop Interventional Coil 0.55T | 2024-06-07 |
| US | K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | 2022-04-08 |
| US | K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T | 2022-03-03 |
| CA | 88878 | 8-CH MULTIFUNCTIONAL COIL CLOTHESPINCOIL (CPC) 1.5T/3.0T | Class II |