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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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Instrument tray for dental tools
PRACTICON, INC.
7141914 PUR
In Commercial Distribution

  • 00723896015803 ()
7141914 PUR

  • Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141914 COR
In Commercial Distribution

  • 00723896015797 ()
7141914 COR

  • Instrument tray, reusable
Instrument tray for dental tools
PRACTICON, INC.
7141914 GRE
In Commercial Distribution

  • 00723896015773 ()
7141914 GRE

  • Instrument tray, reusable
No Description
Fujirebio Europe
15687
In Commercial Distribution

  • 05414470156870 ()


  • Laboratory instrument/analyser application software IVD
PhySoft AMS™ is a web application used to obtain, track and trend patient data pertaining to the management of anemia, and to provide a schedule of erythropoiesis stimulating agent (ESA) dosage recommendations to help achieve and maintain target hemoglobin levels in dialysis patients. PhySoft AMS™ is intended to help physicians, nurses, clinicians and anemia managers manage anemia in adult stage 5 chronic kidney disease (CKD) patients.
PHYSICIAN SOFTWARE SYSTEMS, LLC
1
In Commercial Distribution

  • 00861858000303 ()


  • Nephrology information system application software
The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM “for presentation” images must be used. On mobile platforms, this device is not intended for diagnostic use.
Hyland Software Canada ULC
NIL-READ-GLB
In Commercial Distribution

  • 00697978970017 ()


  • Radiological PACS software
The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users. The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.
Genesis Software Innovations LLC
1.29.1
In Commercial Distribution

  • B973PREVIEWSHOULDER0 ()
PREVIEWSHOULDER

  • Image segmentation application software
The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes. Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/
Genesis Software Innovations LLC
2
In Commercial Distribution

  • B973PREOPSHOULDER0 ()


  • Image segmentation application software
No Description
MetaSystems Hard & Software GmbH
Microscopic image acquisition
In Commercial Distribution

  • 04250406460007 ()


  • Laboratory instrument/analyser application software IVD
No Description
MetaSystems Hard & Software GmbH
Medical Device Data System
In Commercial Distribution

  • 04250406401000 ()


  • Clinical management support software IVD
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