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510(k) Data Aggregation
K Number
K111321Device Name
REMOTE VIEW SOFTWAREManufacturer
Date Cleared
2011-05-17
(6 days)
Product Code
Regulation Number
872.1745Type
SpecialPanel
DentalReference & Predicate Devices
Why did this record match?
Device Name :
REMOTE VIEW SOFTWARE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.
Device Description
Not Found
AI/ML Overview
This document only contains marketing and regulatory information and does not contain the information required to answer the request. The document is a 510(k) premarket notification approval letter for the CarieScan PRO device. It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory requirements. It doesn't include details about acceptance criteria or specific study results beyond the general "indications for use."
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