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510(k) Data Aggregation
K Number
K981398Device Name
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
Manufacturer
Date Cleared
1998-06-01
(45 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
INTERNEURON PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AnatoMark Noninvasive Head Reference System is an accessory for routine head MR that is designed to provide reproducible anatomical markers. The Head Reference System is designed to aid in patient positioning to achieve consistent anatomical images over multiple imaging sessions. The head localizer produces a set of six fiduciary marks on axial images that are positioned reproducibly with reference to stable anatomical structures internal to the patient's cranium. The fiduciary marks are also visible in CT images, making possible the co-registration of CT and MR images.
Device Description
The AnatoMark Noninvasive Head Reference System is a simple device, worn externally on the head, designed for use in routine head or brain MRI to provide reference markers that are visible on magnetic resonance (MR) images. The AnatoMark Noninvasive Head Reference System is intended to provide fiduciary marks that are visible on magnetic resonance (MR) images. The device may also be used to provide MRI/CT co-registration of fiduciary marks. The device is worn externally on the head, is simple and non-invasive, and wearing it is somewhat similar to the wearing of eyeglasses. The device is intended to be used with the "scout" or localization image sequence to establish a reproducible reference plane within the MR system's imaging coordinate system for the subsequent imaging session. At each of three reference locations on the device there is a reference block that contains two reference tubes that appear on MR images. The reference marks are physically implemented as cylinders set in the reference block such that they are orthogonal to each other and cross at their midpoints. When imaged slightly out of plane of the midpoints, the cross-sections of the small cylinders appear as two fiduciary marks that are not side by side. When imaged in the plane of the midpoints, however, the fiduciary marks are side by side. By adjusting the plane of the images such that all three pairs of reference marks show side by side, a reproducible reference plane may be established.
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