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510(k) Data Aggregation
K Number
K020268Device Name
ISAAC 1.5 T MR SYSTEM
Manufacturer
Date Cleared
2002-04-25
(90 days)
Product Code
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
CHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis.
Device Description
The ISAAC 1.5 T MR System is a new clinical whole-body MR system, utilizing a superconducting magnet operating at 1.5 T. A variety of pulse sequences are available as described in Section II. The system is provided with transmit/receive head and body coils, along with several receive-only specialty coils. The system utilizes an actively shielded gradient coil.
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K Number
K962107Device Name
IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5
Manufacturer
Date Cleared
1996-06-20
(20 days)
Product Code
Regulation Number
886.5850Why did this record match?
Applicant Name (Manufacturer) :
LEONACHI, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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