Curve Image™

GUDID D848CURVEIMAGE0

Curve Image™ is a cloud-based dental image acquisition and 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 Dental Ltd

Radiology picture archiving and communication system workstation

• Primary Device ID: D848CURVEIMAGE0
• NIH Device Record Key: 9d08583e-ecc4-41f8-98a3-89f687960e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curve Image™
• Version Model Number: CURVE-IMAGE-I
• Company DUNS: 202952487
• Company Name: Curve Dental Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D848CURVEIMAGE0 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-10

Devices Manufactured by Curve Dental Ltd

• D848CURVEHERO0 - Curve Hero™: 2018-03-29 Curve Dental® develops and markets a cloud-based dental practice management system titled Curve Hero™. Using a Mac or PC plat
• D848CURVEIMAGE0 - Curve Image™: 2018-03-29Curve Image™ is a cloud-based dental image acquisition and 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.
• D848CURVEIMAGE0 - Curve Image™: 2018-03-29 Curve Image™ is a cloud-based dental image acquisition and management system that provides Internet access to an image library