Conditional 6 - This implant/device was determined to be MR Conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Non-clinical testing demonstrated that the implant/device is MR Conditional. A patient with this implant/device can be scanned safely immediately after placement under the following conditions:
• Static magnetic field of 3-Tesla or less
• Maximum spatial gradient magnetic field of 720-gauss/cm (a higher spatial gradient magnetic field value may apply)
• Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2-W/kg (i.e., the Normal Operating Mode) for 15 minutes of scanning (per pulse sequence).
In non-clinical testing, the implant/device produced a temperature rise of less than or equal to 6.0 degrees C using an MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15-minutes (per pulse sequence) of scanning in a 3-Tesla MR system.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the implant/device. In some cases, the artifact size relative to the size of the implant or device may be indicated.
Attention: Contact the manufacturer of this implant/device for further information, as needed.
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Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.
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