직접 확인해 보세요
쓰시던 MRI 장비의 잠재력을 말이죠.
FDA 510(k) 승인
신고 및 승인 완료
- Class B approved by the Vietnam Ministry of Health
- Class C approved by the Indonesia Ministry of Health
- Approved by Hong Kong MDD as Class II
- Approved by Malaysia MDA as Class B
- Notified to Brazil ANVISA as Class II
- Notified to Philippines FDA as Class B
- Cleared by UAE MOHAP as Medical Device
- Approved by Singapore HSA as Class B
- Approved by Saudi Arabia SFDA as Class B
- Approved by Thailand TFDA as Class 2
- Included in the ARTG entry by Australian TGA as Class IIa
*SwiftMR의 향후 다른 지역에서의 가용성은 보장할 수 없습니다.
향후 규제 상태에 대한 모든 업데이트는 당사 웹사이트에서 확인할 수 있습니다.