HSA · registration DE0507628Philips MRI Coils
SingaporeRadiology / ImagingClass BPhilips Medical Systems Nederland B.V.
Official record identity
- Registration number
- DE0507628
- Model name
- 1.5T 8-ch TR Knee coil; 3.0T HD T/R KNEE ARRAY; HD 8Ch WRIST ARRAY (Receive Only); 3.0T HD T/R QUAD EXTREMITY COIL; 1.5T HD T/R QUAD EXTREMITY COIL; HD 8Ch Wrist Array; HD 8Ch Foot Ankle Coil; 1.5T HD T/R Knee Coil (flat base); 1.5T HD T/R QUAD EXTREMITY COIL (flat base); HD 8CH Wrist Array; 1.5T 32Ch Cardiac Coil- Anterior; 3.0T HD T/R Knee Coil (flat base); 3.0T HD T/R Quad Extremity Coil (flat base); HD 8Ch Wrist Array; 3.0T 32Ch Cardiac Coil - Anterior; 16Ch Shoulder Coil; 16Ch Shoulder Coil
- Model identifier
- M3087JF; M3335LB; M3335LJ; M3335LP; M3335ME; M3340CA; M3340CD; M7000FS; M7000FT; M7000FW; M7000FY; M7000GS; M7000GT; M7000GW; M7000GY; M7006CA; M7006CB
- Registration date
- December 22, 2022
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Philips Medical Systems Nederland B.V.
- Registrant / registration holder
- GE HEALTHCARE PTE. LTD.
Official description
The MR Coil is intended to be used in conjunction with a GE Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
Additional source fields
- Product owner address
- Veenpluis 6, 5684 PC Best, Netherlands
- Registrant address
- 11 NORTH BUONA VISTA DRIVE, #11-07, THE METROPOLIS, Singapore 138589
About this record
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.