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510(k) Data Aggregation
K Number
K112974Device Name
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer
CURVE DENTAL, INC.
Date Cleared
2011-10-20
(15 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CURVE DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 a web-based dental practice image management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer.
Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called HERO.
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K Number
K110139Device Name
CURVE IMAGE
Manufacturer
CURVE DENTAL, INC.
Date Cleared
2011-04-21
(93 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CURVE DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, treatment plans, clinical notes, audit recording and clinical exam data. The system uses a Web-based interface and includes the editing and storage of digital images. The system is designed to be a single source solution for a dental practice.
Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images cannot be acquired from standard dental imaging devices, but can be uploaded directly from the user's computer. Images can be edited (e.g., resized, contrast, cropped, etc.), as well as exported.
Device Description
Curve Image is a web-based dental practice image management system that provides Internet access to an image library for each patient in a practice. It also provides tools for dental practices to manipulate patient images and both acquire and upload new images in industry standard formats. Images can be annotated and tagged, and are available for both diagnostic and non-diagnostic use. All of these actions are performed from a secure website, after entering user credentials, similar to other commonly used online applications. The system can be accessed by the user via an internet connection and does not require any software installation on the user's computer.
Curve Image may be sold as a stand-alone product, or may be bundled with a suite of web applications to form a comprehensive dental practice management application called "Curve Hero". Curve Hero is a patient scheduling and billing application that is provided as a stand-alone or in combination with Curve Image. Curve Hero is not a medical device and therefore is outside the scope of this submission.
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