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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Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
7
In Commercial Distribution

  • 00884838115378 ()
830089

  • Radiology picture archiving and communication system workstation
IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as, but not limited to, CT and MRI, or from image archives. IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
IntelliSpace Clinical Applications - 8
In Commercial Distribution

  • 00884838125940 ()
837509

  • Radiology picture archiving and communication system workstation
IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP as well as hospital/radiology information systems. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.
Philips Medical Systems Nederland B.V.
IntelliSpace Radiology - 4
In Commercial Distribution

  • 00884838123809 ()
836344

  • Radiology picture archiving and communication system workstation
IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac patients across their complete cardiovascular care continuum. The application also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow–up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available. The solution supports a remote deployment model.
Philips Medical Systems Nederland B.V.
8
In Commercial Distribution

  • 00884838122000 ()
830089

  • Radiology picture archiving and communication system workstation
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images. For example the Sectra Orthopaedic Package shall: • Assist the orthopaedic surgeons in choosing which implants to use. • Assist the orthopaedic surgeons in choosing where to place cut lines etc. • Assist the orthopaedic surgeons in following-up of surgical procedures. • Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery. • Assist the radiologist in making MSK measurements. • Assist the user in producing outputs for post-processing such as 3D prints of anatomical models. Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.
Sectra AB
19.1
In Commercial Distribution

  • 07350092810609 ()


  • Radiology picture archiving and communication system workstation
No Description
Roche Diagnostics GmbH
4642465190
Not in Commercial Distribution

  • 04015630997954 ()
4642465190

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Kit Includes: R144 Queen of Hearts™ R138BC Montana Jack® (Breast Cancer Pink) R120 Montana 4-5™ Scaler R044 Amazing Gracey™ 15-16 Extended Reach R043 Amazing Gracey™ 13-14 Extended Reach R093 N128-L5 Mini R067 Columbia 4L-4R T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7
PDT, INC.
R976 Perio Maintenance Kit
In Commercial Distribution

  • 00813677024442 ()
R976

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
Kit Includes: R144 Queen of Hearts™ R138BC Montana Jack® (Breast Cancer Pink) R120 Montana 4-5™ Scaler R044 Amazing Gracey™ 15-16 Extended Reach R043 Amazing Gracey™ 13-14 Extended Reach R093 N128-L5 Mini R067 Columbia 4L-4R T007B-F FlipTop™ Cassette 'B' - Fixed Rack 7
PDT, INC.
R975 SRP Kit
In Commercial Distribution

  • 00813677024435 ()
R975

  • Periodontal curette
  • Manual dental scaler, reusable
  • Instrument tray, reusable
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.9.9060
In Commercial Distribution

  • B359PSPACS6PRU90 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.7.7221
In Commercial Distribution

  • B359PSPACS6PRU720 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
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