Curve Image™

Basic Information

• Brand Name: Curve Image™
• Primary DI: D848CURVEIMAGE0
• Version / Model: CURVE-IMAGE-I
• Company Name: Curve Dental Ltd
• Labeler DUNS: 202952487
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 9d08583e-ecc4-41f8-98a3-89f687960e6b

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40943	Radiology picture archiving and communication system workstation	A freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D848CURVEIMAGE0	HIBCC