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Found 5 results
510(k) Data Aggregation
K Number
K022074Device Name
SPHERZ
Manufacturer
I.Z.I. CORP.
Date Cleared
2002-08-13
(48 days)
Product Code
HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy.
Device Description
Not Found
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K Number
K014022Device Name
MRI LINE MARKER
Manufacturer
I.Z.I. CORP.
Date Cleared
2002-03-04
(88 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as permanently-filled and -sealed artificial fiduciary markers with the head rings and localizer I brass as permanently and systems in order to facilitate localizing and documenting the precise superimposition of CT and MRI imaging data.
Device Description
Not Found
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K Number
K003736Device Name
MRI LINE MARKER
Manufacturer
I.Z.I. CORP.
Date Cleared
2001-01-18
(45 days)
Product Code
JAK, JAA, KPS, LHN
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994117Device Name
MR ENHANCER
Manufacturer
I.Z.I. CORP.
Date Cleared
2000-02-04
(60 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo. MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.
Device Description
MR Enhancer
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K Number
K993742Device Name
SUPER TISSUE
Manufacturer
I.Z.I. CORP.
Date Cleared
2000-02-02
(90 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue.
Device Description
Not Found
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