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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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IntelliSpace PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Philips Healthcare Informatics, Inc.
IntelliSpace PACS - 4
In Commercial Distribution

  • 00884838074781 ()
837507

  • Radiology picture archiving and communication system workstation
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, image manipulation, communication and storage. I4 (Integrated Intelligent Imaging Informatics) is offering a primary interpretation solution for reviewing and analysing a large variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 integrates with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Philips Medical Systems Nederland B.V.
1.x
In Commercial Distribution

  • 00884838074743 ()


  • 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
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
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image. For use with internally administered radioactive products. UniSyn can estimate radiation dose from internalized radioactivity in the human body as a result of a diagnostic or therapeutic medical procedure involving radioactive materials. UniSyn should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Convergent Imaging Solutions Incorporated
7-4-1-PX
In Commercial Distribution

  • B843UNISYN7410 ()


  • Radiology picture archiving and communication system workstation
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT, MR and other medical scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.
Convergent Imaging Solutions Incorporated
7-3-4-PX
In Commercial Distribution

  • B843UNISYN7340 ()


  • Radiology picture archiving and communication system workstation
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