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510(k) Data Aggregation
K Number
K973035Device Name
VIOLA II DENTAL CAMERA SYSTEM
Manufacturer
Date Cleared
1997-09-24
(41 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Viola II Dental Camera system is designed for use in the following applications:
1. To allow the clinician to provide the patient with accurate information
2. To allow the clinician to provide educational information to the patient as well as other clinical personnel
3. To provide documentation for patient records
4. To assist the clinician in the diagnosis of oral cancer and gum diseases
5. To provide documentation for insurance companies
Device Description
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