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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No Description
Avreo Inc
Version 8.6.0.21040
In Commercial Distribution

  • 00850054590084 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
Version 8.6.0.20992
In Commercial Distribution

  • 00850054590077 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
Version 8.6.0.20917
In Commercial Distribution

  • 00850054590060 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
Version 8.6.0.20860
In Commercial Distribution

  • 00850054590053 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
8.6.0.20824
In Commercial Distribution

  • 00850054590046 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
8.5.0.20530
In Commercial Distribution

  • 00850054590039 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
8.5.20530
Not in Commercial Distribution

  • 00850054590022 ()


  • Radiological PACS software
  • Radiology information system
No Description
Avreo Inc
8.5.20356
In Commercial Distribution

  • 00850054590015 ()


  • Radiological PACS software
  • Radiology information system
ViewPoint 6 v6.14
GE Healthcare GmbH
6. ver14
In Commercial Distribution

  • 00195278517340 ()
H47591YA

  • Medical image management system
  • Radiological PACS software
ViewPoint 6 ver 6.9
GE Healthcare GmbH
6. ver6.9
Not in Commercial Distribution

  • 00840682124454 ()


  • Radiological PACS software
  • Medical image management system
ViewPoint 6 v6.12
GE Healthcare GmbH
6. ver12
In Commercial Distribution

  • 00840682171953 ()


  • Medical image management system
  • Radiological PACS software
ViewPoint 6 v6.11
GE Healthcare GmbH
6. ver11
Not in Commercial Distribution

  • 00840682145718 ()


  • Medical image management system
  • Radiological PACS software
ViewPoint 6 v6.10
GE Healthcare GmbH
6. ver10
Not in Commercial Distribution

  • 00840682140744 ()


  • Medical image management system
  • Radiological PACS software
No Description
GE Healthcare GmbH
6 ver6.8
Not in Commercial Distribution

  • 00840682119627 ()


  • Radiological PACS software
  • Medical image management system
No Description
GE Healthcare GmbH
ver5.6
Not in Commercial Distribution

  • 00840682119610 ()


  • Medical image management system
  • Radiological PACS software
No Description
GE Healthcare GmbH
6 ver 6.7
Not in Commercial Distribution

  • 00840682103640 ()


  • Radiological PACS software
  • Medical image management system
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
MACES Back Interface Kit includes mounting hardware to affix a Matrx Elite back (width range of 14W-18W) onto a Motion Concepts Power Positioning System with Recline. MACES hardware allows the for full rotational (multi-axis) angle adjustment of the back support.
Motion Concepts Inc
D-0139-EBMI
In Commercial Distribution

  • 07540147002930 ()
EBMI

  • Wheelchair bracket/mount
  • Wheelchair back rest positioner
Manometer, Pole Mount Clamp, MRI Cond 3T, for 3/8" to 1.5" dia Pole, w/Hardware, fits 00-199-MRI Gauges
ANESTHESIA ASSOCIATES, INC.
00-200-S-MRI
In Commercial Distribution

  • B00500200SMRI0 ()
00-200-S-MRI

  • Airway pressure monitor, non-powered
Manometer, Pole Mount Clamp, Large, for 3/8" to 1.5" dia Pole, w/Hardware, fits all 00-199, 00-274 Gauges
ANESTHESIA ASSOCIATES, INC.
00-200-S
In Commercial Distribution

  • B00500200S0 ()
00-200-S

  • Airway pressure monitor, non-powered
Visix 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007054 ()
Visix 8.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software
Visix Pro software version 7.7.15
TELEVERE SYSTEMS, LLC
7.7.15
In Commercial Distribution

  • 00851800007047 ()
Visix Pro 7.7.15

  • Basic diagnostic x-ray system application software
  • Camera application software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
Visix software version 2.3.9
TELEVERE SYSTEMS, LLC
2.3.9
In Commercial Distribution

  • 00851800007030 ()
Visix 2.3.9

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Camera application software
  • Basic diagnostic x-ray system application software
HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
Software, Version 2.0, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1064270
In Commercial Distribution

  • M65810642700 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system
Software, Accuray Precision Treatment Planning System, (Version 1.1.1.1) The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1061799
In Commercial Distribution

  • M65810617990 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer
Software, Version 1.1.1, Accuray Precision Treatment Planning System The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1059811
In Commercial Distribution

  • M65810598110 ()
NA

  • Radiation therapy treatment planning computer
  • Linear accelerator system
Software, Version 1.0.0.1, Accuray Precision Treatment Planning System, The Accuray Precision Treatment Planning System is a radiation therapy planning system used for creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.
ACCURAY INCORPORATED
1055096
In Commercial Distribution

  • M65810550960 ()
NA

  • Linear accelerator system
  • Radiation therapy treatment planning computer
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