This company has registrations in United States, Brazil, Canada, Singapore, Australia — 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 | K250064 | Dose+ (1.0) | 2025-09-04 |
| US | K241490 | Contour+ (MVision AI Segmentation) | 2024-10-18 |
| US | K212915 | MVision AI Segmentation | 2022-05-03 |
| BR | 81346500072 | MVision AI Segmentation | Class II |