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510(k) Data Aggregation
K Number
K990242Device Name
TOPOGRAPHIC IMAGING MARKER
Manufacturer
Date Cleared
1999-03-03
(37 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 121 Topographic Imaging Marker provides a location on the patient's skin to reference internal anatomy and pathology. Given any radiographic information thereby, a physician or technician can pinpoint the location of the patient's ailment on the skin surface in reference to an internal pathologic process. The subsequent radiographic study would enable one to cross reference the skin position indicated by the patient with the internally demonstrated pathologic process shown on the study.
The IZI Topographic Imaging Marker is used for all fluoroscopic procedures, all standard radiographic procedures, localization of internal anatomy and pathology, as well as being able to direct biopsy procedures.
Device Description
Topographic Imaging Marker
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K Number
K990298Device Name
TOPOGRAPHIC IMAGING MARKER
Manufacturer
Date Cleared
1999-03-03
(30 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IZI Topographic Imaging Marker provides a location on the patient's skin to reference internal anatomy and pathology. Given any radiographic information thereby, a physician or technician can pinpoint the location of the patient's ailment on the skin surface in reference to an internal pathologic process. The subsequent radiographic study would enable one to cross reference the skin position indicated by the patient with the internally demonstrated pathologic process shown on the study.
The IZI Topographic Imaging Marker is used for all fluoroscopic procedures, all standard radiographic procedures, localization of internal anatomy and pathology, as well as being able to direct biopsy procedures.
Device Description
Not Found
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K Number
K964972Device Name
SHADOWFORM
Manufacturer
Date Cleared
1997-05-05
(144 days)
Product Code
Regulation Number
892.5840Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K962606Device Name
TOPOGRAPHIC IMAGING MARKER
Manufacturer
Date Cleared
1996-08-07
(36 days)
Product Code
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
I.Z.I. MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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