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Found 3 results
510(k) Data Aggregation
K Number
K974423Device Name
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
Manufacturer
STERLING DIAGNOSTIC IMAGING, INC.
Date Cleared
1997-12-22
(28 days)
Product Code
EAM
Regulation Number
892.1960Why did this record match?
Product Code :
EAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These radiographic intensifying screens have application whenever a high image quality radiographic examination such as mammography is required.
Device Description
Ultra-Vision® Mammography Detail and Ultra-Vision® Mammography Fast Detail are ultraviolet activated rare earth intensifying screens. The phosphor is niobium activated lutetium tantalate.
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K Number
K963913Device Name
MD100 & MM150
Manufacturer
KONICA MEDICAL CORP.
Date Cleared
1997-10-08
(373 days)
Product Code
EAM
Regulation Number
892.1960Why did this record match?
Product Code :
EAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Accessory to a cassette to convert X-Ray energy into light energy.
Device Description
Not Found
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K Number
K954161Device Name
JPI INTENSIFYING SCREEN
Manufacturer
JPI HEALTHCARE CO., LTD
Date Cleared
1996-02-02
(150 days)
Product Code
EAM
Regulation Number
892.1960Why did this record match?
Product Code :
EAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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