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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Xcelera MR/CT Viewer is an image processing workstation software package designed to run on standard PC hardware. The ViewForum software receives image files from medical scanning devices, such as CT or MRI, or from image archives and performs viewing, image manipulation, communication and printing and quantification of images.
Philips Medical Systems Nederland B.V.
6.1
In Commercial Distribution

  • 00884838070660 ()


  • Radiology picture archiving and communication system workstation
Philips Xcelera software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital medical images.
Philips Medical Systems Nederland B.V.
4.1
In Commercial Distribution

  • 00884838070646 ()


  • Radiology picture archiving and communication system workstation
Software medical device, used with a Philips Interventional X-Ray System. Creates 3D views of vessels and bones from sets of 2D images from rotational angiographic runs.
Philips Medical Systems Nederland B.V.
Allura 3D-RA - 6
In Commercial Distribution

  • 00884838059214 ()
001002

  • Radiology picture archiving and communication system workstation
No Description
CANON MEDICAL SYSTEMS CORPORATION
CUW-U001S
In Commercial Distribution

  • 04987670104374 ()


  • Ultrasound imaging 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
6.0.9.9061
In Commercial Distribution

  • B359PSPACS6PRU9GA0 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.9.9110
In Commercial Distribution

  • B359PSPACS6PRU910 ()


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