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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
CURVE-IMAGE-I
In Commercial Distribution

  • D848CURVEIMAGE0 ()


  • Radiology picture archiving and communication system workstation
Curve Dental® develops and markets a cloud-based dental practice management system titled Curve Hero™. Using a Mac or PC platform, a dental practice can use Curve Hero™ to manage all aspects of their practice, from scheduling to charting to billing, or from front desk to operatory. The application provides for secure and redundant management of all patient records and patient communications. Additionally, when utilizing Curve Dental’s® Curve Image™, the practice can also capture digital images directly to the cloud.
Curve Dental Ltd
CURVE-HERO-I
In Commercial Distribution

  • D848CURVEHERO0 ()


  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
3.1
In Commercial Distribution

  • 04056481142810 ()
39010

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
4.1
Not in Commercial Distribution

  • 04056481140519 ()


  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.5
Not in Commercial Distribution

  • 04056481140502 ()


  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
4.0
Not in Commercial Distribution

  • 04056481139049 ()
30074-03S

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
5.1
Not in Commercial Distribution

  • 04056481138868 ()
21306-02B

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.4
Not in Commercial Distribution

  • 04056481138615 ()
25100-12B

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
3.4
Not in Commercial Distribution

  • 04056481138226 ()
30074-03O

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.3.1
Not in Commercial Distribution

  • 04056481132453 ()
25100-12A

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
3.4
Not in Commercial Distribution

  • 04056481132224 ()
30074-03N

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
26217-02D
Not in Commercial Distribution

  • 04056481006846 ()
26217-02E

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.3
Not in Commercial Distribution

  • 04056481006662 ()
25100-12

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
15600
Not in Commercial Distribution

  • 04056481006648 ()
15600

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
15610
Not in Commercial Distribution

  • 04056481006631 ()
15610

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
54200B
Not in Commercial Distribution

  • 04056481001797 ()
54200B

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
1
Not in Commercial Distribution

  • 04056481000431 ()
26200-02B

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
1
Not in Commercial Distribution

  • 04056481000363 ()
26217-02A

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
2.0
Not in Commercial Distribution

  • 04056481000356 ()
26217-02B

  • Radiology picture archiving and communication system workstation
No Description
Brainlab AG
3.2
In Commercial Distribution

  • 04056481146221 ()


  • Radiology picture archiving and communication system workstation
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10853679
Not in Commercial Distribution

  • 04056869003528 ()


  • Ultrasound imaging system workstation
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10433921
In Commercial Distribution

  • 04056869003504 ()


  • Ultrasound imaging system workstation
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10438904
Not in Commercial Distribution

  • 04056869003498 ()


  • Ultrasound imaging system workstation
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10520828
In Commercial Distribution

  • 04056869002323 ()


  • Nuclear medicine system workstation
Standalone software application
MERGE HEALTHCARE SOLUTIONS INC.
6.6
In Commercial Distribution

  • 00842000101178 ()


  • Radiology picture archiving and communication system workstation
No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.5
In Commercial Distribution

  • 00842000101161 ()


  • Radiology picture archiving and communication system workstation
No Description
MERGE HEALTHCARE SOLUTIONS INC.
9.2
In Commercial Distribution

  • 00842000101154 ()


  • Radiology picture archiving and communication system workstation
No Description
MERGE HEALTHCARE SOLUTIONS INC.
9.1
In Commercial Distribution

  • 00842000101147 ()


  • Radiology picture archiving and communication system workstation
No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.4
In Commercial Distribution

  • 00842000101130 ()


  • Radiology picture archiving and communication system workstation
Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.
MERGE HEALTHCARE SOLUTIONS INC.
12.4
In Commercial Distribution

  • 00842000101123 ()


  • Radiology picture archiving and communication system workstation
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