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Ambicor product line is MR Conditional.
The device can be scanned safely under
the following conditions:
Static
Magnetic
Field
Spatial
Gradient Field
Maximum
whole body
averaged
Specific
Absorption
Rate (SAR)
MRI-Related Heating
Non-clinical testing has demonstrated
the Ambicor product line produced the
temperature rises during MRI performed
for 15 minutes of scanning in the
respective MR systems which would not
pose a hazard to the human subject.
Static Magnetic Field
Highest Temperature
Change
(a) 1.5T - 64 MHz MR System (General Electric
Healthcare, Milwaukee, WI)
(b) 3.0T MR Excite, General Electric Healthcare,
software version 14X.M5
Artifact Information
Non-clinical testing has demonstrated that
the Ambicor product line may compromise
the MR image quality if the area of interest
is relatively close to the position of the
implant. The maximum image artifact
produced by a MR gradient echo pulse
sequence was a "moderate" localized signal
void in size and shape of the implant.
Optimization of MR imaging parameters to
compensate for the presence of the device
may be necessary.
Pulse
T1-SE
Sequence
Signal
6,244
Void Size
mm
1.5 Tesla
a
450 Gauss/cm
or less
1.5 W/kg for
15 minutes of
scanning as
assessed by
calorimetry
1.5 Tesla
a
≤ + 0.4° C
T1-SE
GRE
1,589
10,295
mm
mm
2
2
3.0 Tesla
b
720 Gauss/cm
or less
2.9 W/kg for
15 minutes of
scanning as
assessed by
calorimetry
3.0 Tesla
b
≤ + 1.9 ° C
GRE
2,779
mm
2
2
17
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