30 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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BIC TOOL JAPAN
FDA registration
BIC TOOL JAPAN·1 product·🇯🇵 Japan
Aquilion Precision (TSX-304A/4) V10.14 with AiCE
FDA 510(k)
FDA Class 2
·Radiology
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
FDA 510(k)
FDA Class 2
·Radiology
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
FDA 510(k)
FDA Class 2
·Radiology
Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
FDA 510(k)
FDA Class 2
·Radiology
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
FDA 510(k)
FDA Class 2
·Radiology
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
FDA 510(k)
FDA Class 2
·Radiology
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
FDA 510(k)
FDA Class 2
·Radiology
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology