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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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Viz HCM v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution

  • 00811852030332 ()


  • Cardiopulmonary physiological parameter analysis software
Viz RV/LV v1.2 (2023-04-19)
VIZ.AI, INC.
Viz RV/LV Software
In Commercial Distribution

  • 00811852030295 ()


  • Radiology DICOM image processing application software
Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy. The software provides a range of features, including: - 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP). - 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering. - Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning. - Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices. The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.
EWOO SOFT Co., Ltd
1.0
In Commercial Distribution

  • 08800019700593 ()


  • General-purpose dental x-ray system application software
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution

  • 17540262150018 ()


  • Radiological PACS software
PREOPERATIVE FITBONE MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469470008 ()
FITBONEMODULESW

  • Radiological PACS software
No Description
Chengdu Wision Medical Device Co., Ltd.
WIPD01
In Commercial Distribution

  • 06973770840012 ()


  • Endoscopic video image interpretive software
SW B36104S SURETUNE4 DBS SERVER
MEDTRONIC, INC.
B36104S
In Commercial Distribution

  • 00763000421212 ()
  • 00763000496456 ()


  • Implantable electrical stimulation device management software
SW B36104C SURETUNE4 DBS CLIENT
MEDTRONIC, INC.
B36104C
In Commercial Distribution

  • 00763000421212 ()
  • 00763000496449 ()


  • Implantable electrical stimulation device management software
SW B36104A SURETUNE4 DBS STANDALONE
MEDTRONIC, INC.
B36104A
In Commercial Distribution

  • 00763000421212 ()
  • 00763000496432 ()


  • Implantable electrical stimulation device management software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_UI
In Commercial Distribution

  • 07290019352037 ()


  • Ultrasound imaging system application software
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