Search Results
Found 2 results
510(k) Data Aggregation
K Number
K002242Device Name
POLESTAR N-10
Manufacturer
Date Cleared
2000-09-20
(58 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ODIN TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
K Number
K991243Device Name
NORMA 10
Manufacturer
Date Cleared
1999-06-18
(67 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
ODIN TECHNOLOGIES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. When interpreted by trained physicians, these images provide information that can be useful in determining a diagnosis.
- Anatomical regions: extremities and selected sections of the . head.
- H-1 Nuclei excited: .
- Diagnostic uses: T1, T2, T2* and density weighted . imaging.
Device Description
The NORMA 10 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The NORMA 10 is a fixed system. ODIN Technologies Ltd., has developed an open MRI system based on an innovatively designed permanent magnet of 0.12 Tesla. The system is compact, displaceable, inexpensive and widely open. The magnetic probe consists of two lateral permanent-magnet poles that can be adjusted laterally and longitudinally, mounted on a C-arm gantry. The anatomic region to be scanned is positioned between the poles. Except for the anatomic region been scanned, the patient is positioned outside of the gantry, thus enhancing patient comfort and reducing the possibility of a claustrophobic reaction.
Ask a Question
Ask a specific question about this device
Page 1 of 1