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510(k) Data Aggregation
K Number
K173101Device Name
Curve Image 2.0 PACS
Manufacturer
Date Cleared
2017-10-18
(19 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Curve Dental LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Curve Image is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.
Device Description
Curve Image is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.
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