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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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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
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
6
In Commercial Distribution

  • 00884838106970 ()
830089

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
5
In Commercial Distribution

  • 00884838100107 ()
830089

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
4.2
In Commercial Distribution

  • 00884838095250 ()
830089

  • Radiology picture archiving and communication system workstation
illumeo 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. illumeo 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. illumeo 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.
v2.2
In Commercial Distribution

  • 00884838093997 ()
45980163324X

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular 4.1
In Commercial Distribution

  • 00884838093072 ()
98960612681X

  • Radiology picture archiving and communication system workstation
Philips 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. Philips IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. Philips IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Healthcare Informatics, Inc.
IntelliSpace Clinical Applications - 8
In Commercial Distribution

  • 00884838091849 ()
837509

  • Radiology picture archiving and communication system workstation
IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, 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 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. Mammography images may only be interpreted using display monitors approved for digital mammography.
Philips Healthcare Informatics, Inc.
IntelliSpace Radiology - 4
In Commercial Distribution

  • 00884838091740 ()
836344

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
3.2
In Commercial Distribution

  • 00884838091429 ()
98960612660X

  • Radiology picture archiving and communication system workstation
illumeo 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. illumeo 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. illumeo 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.
v2.x
In Commercial Distribution

  • 00884838087958 ()
45980141116X

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular 3.1
In Commercial Distribution

  • 00884838087460 ()
98960612483X

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
2.3
In Commercial Distribution

  • 00884838085770 ()
98960612341x

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular 2.2
In Commercial Distribution

  • 00884838085220 ()
98960612323X

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
IntelliSpace Cardiovascular 1.2
In Commercial Distribution

  • 00884838076730 ()


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

  • 04987670104374 ()


  • Ultrasound imaging 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
6.0.5.5040
In Commercial Distribution

  • B359PSPACS60 ()
PSPACS6

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway
Ramsoft Inc
6.0.11.11031A
In Commercial Distribution

  • B359PSGWY6PRU11A0 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway Router 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSGWR6PRU110 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
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
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
6.0.8.8111
In Commercial Distribution

  • B359PSPACS6PRU80 ()


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

  • B359PSPACS6PRU720 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.7.7115
In Commercial Distribution

  • B359PSPACS6PRU70 ()
PSPACS6PRU7

  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft PowerServer PACS
Ramsoft Inc
6.0.6.6015
In Commercial Distribution

  • B359PSPACS6PRU60 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.5.5100
In Commercial Distribution

  • B359PSPACS6PRU510 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSPACS6PRU110 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft PowerServer PACS 6
Ramsoft Inc
6.0.10.10100
In Commercial Distribution

  • B359PSPACS6PRU100 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data.
Ramsoft Inc
6.0.11.11031B
In Commercial Distribution

  • B359PSGWY6PRU11B0 ()
PSGWY6PRU11B

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway 6
Ramsoft Inc
6.0.11.11031
In Commercial Distribution

  • B359PSGWY6PRU110 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
OmegaAI Image Viewer
Ramsoft Inc
1.0
In Commercial Distribution

  • B359OAIIV11 ()
OAIIV1

  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.9.9061
In Commercial Distribution

  • B359GWY6PRU9GA0 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.9.9110
In Commercial Distribution

  • B359GWY6PRU910 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.9.9060
In Commercial Distribution

  • B359GWY6PRU90 ()


  • Radiological PACS software
  • Radiology picture archiving and communication system workstation
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.8.8111
In Commercial Distribution

  • B359GWY6PRU80 ()


  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
RamSoft Gateway QC/Viewer 6
Ramsoft Inc
6.0.7.7221
In Commercial Distribution

  • B359GWY6PRU720 ()


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