HSA · registration DE0507627Philips Sentinelle Vanguard Breast MRI Table and Tabletop Coil
- Registration number
- DE0507627
- Model name
- Vanguard Breast MRI Tabletop Coil; Vanguard Breast MRI Table; Vanguard Breast MRI Tabletop Coil
- Model identifier
- M3340CW; M7000FG; M7000FJ
- Registration date
- December 22, 2022
- Risk class
- Class B
- Product owner
- Philips Medical Systems Nederland B.V.
- Registrant / registration holder
- GE HEALTHCARE PTE. LTD.
The Breast MRI Table and Tabletop are designed to provide magnetic resonance (MR) images of breast anatomy when used in conjunction with a GE MR scanner. The images can be interpreted by a trained physician. When used with a single-use biopsy grid, the Sentinelle Breast MRI Table and Tabletop for GE permit access to the breast anatomy for biopsy and localization procedures that can be performed by a trained physician.
- Product owner address
- Veenpluis 6, 5684 PC Best, Netherlands
- Registrant address
- 11 NORTH BUONA VISTA DRIVE, #11-07, THE METROPOLIS, Singapore 138589
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.