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510(k) Data Aggregation
K Number
K984030Device Name
VIPERSOFT
Manufacturer
Date Cleared
1999-02-10
(90 days)
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The software, Vipersoft, for extraoral X-ray units is used to process digital images from extraoral X-ray units in order to enable a dentist to diagnose the dental state of the teeth of a patient.
Device Description
Software for extraoral X-ray units
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K Number
K981534Device Name
VIPERCAM
Manufacturer
Date Cleared
1998-07-23
(85 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intraoral camera system, Vipercam, of Integra Medical Corporation is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
Device Description
Vipercam, intraoral camera system, and accessories
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