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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VISION RT LIMITED
Workstation Z4 - IGB CS ART
In Commercial Distribution

  • 05056190500221 ()


  • Radiological video camera patient positioning/tracking system
Workstation Z4 - IGC TrueBeam AlignRT
VISION RT LIMITED
Workstation Z4 - IGC TB ART
In Commercial Distribution

  • 05056190500214 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Workstation Z4 - OSMS CS
In Commercial Distribution

  • 05056190500207 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Workstation Z4 - OSMS TB
In Commercial Distribution

  • 05056190500191 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HD CAM Gen 5
In Commercial Distribution

  • 05056190500184 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
OSMS 5.1 - TB 115V
In Commercial Distribution

  • 05056190500153 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
OSMS 5.1 115V
In Commercial Distribution

  • 05056190500122 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
OSMS 5.0 - TB 115V
In Commercial Distribution

  • 05056190500115 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Remote Control
In Commercial Distribution

  • 05056190500092 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
OSMS 5.0
In Commercial Distribution

  • 05056190500085 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HD CAM
In Commercial Distribution

  • 05056190500078 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Real Time Coach
In Commercial Distribution

  • 05056190500054 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
GateCT
In Commercial Distribution

  • 05056190500023 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HP Z2 G9 workstation - AlignRT Offline
In Commercial Distribution

  • 05056190500986 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HP Z2 G9 workstation - Patient Data Workstation
In Commercial Distribution

  • 05056190500979 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
HP Z2 G9 workstation - SimRT
In Commercial Distribution

  • 05056190500962 ()


  • Radiological video camera patient positioning/tracking system
DoseRT reference board used with AlignRT Plus systems.
VISION RT LIMITED
DoseRT reference board
In Commercial Distribution

  • 05056190500894 ()
DoseRT reference board

  • Radiological video camera patient positioning/tracking system
Calibration Cube Mk2
VISION RT LIMITED
Calibration Cube Mk2
In Commercial Distribution

  • 05056190500863 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Varian ProBeam Hold - Switch Box
In Commercial Distribution

  • 05056190500795 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Real Time Coach
In Commercial Distribution

  • 05056190500788 ()


  • Radiological video camera patient positioning/tracking system
DoseRT camera used for AlignRT Plus systems.
VISION RT LIMITED
DoseRT camera
In Commercial Distribution

  • 05056190500740 ()
DoseRT camera

  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Calibration Plate Narrow
In Commercial Distribution

  • 05056190500719 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Calibration Plate
In Commercial Distribution

  • 05056190500696 ()


  • Radiological video camera patient positioning/tracking system
Touchless4D version 7.2
VISION RT LIMITED
Touchless4D
In Commercial Distribution

  • 05056190500672 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Fujitsu M7010X
In Commercial Distribution

  • 05056190500665 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
AlignRT InBore 7.0
In Commercial Distribution

  • 05056190500641 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Patient Data Workstation Z2T
In Commercial Distribution

  • 05056190500627 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
AlignRT Offline Z2T
In Commercial Distribution

  • 05056190500610 ()


  • Radiological video camera patient positioning/tracking system
SimRT version 7.2
VISION RT LIMITED
SimRT 7.2
In Commercial Distribution

  • 05056190500597 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Power Supply Unit (PSU)
In Commercial Distribution

  • 05056190500061 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
Head Adjuster
In Commercial Distribution

  • 05056190500047 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
AlignRT Offline
Not in Commercial Distribution

  • 05056190500030 ()


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
GateRT
In Commercial Distribution

  • 05056190500016 ()


  • Radiological video camera patient positioning/tracking system
AlignRT system
VISION RT LIMITED
AlignRT 5.x 115V or 230V
In Commercial Distribution

  • 05056190500009 ()


  • Radiological video camera patient positioning/tracking system
The intended use of the device is to identify the patient and patient specific accessories and to guide the positioning of patients and accessories for radiosurgery or radiotherapy prodedures. The only location where the device is used is the radiologic diagnostic and radiation therapy department.
humediQ global GmbH
1.7
In Commercial Distribution

  • EHUQHQ0100707 ()
HQ01007

  • Radio-frequency identification patient positioning/tracking system application software
The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363056 ()

  • Height: 700 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system
The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363032 ()

  • Height: 800 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system
The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363025 ()

  • Height: 800 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system
The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363018 ()

  • Height: 700 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system
The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.
Tracinnovations A/S
TCL3.2
In Commercial Distribution

  • 05745000363001 ()

  • Height: 800 Millimeter
  • Width: 460 Millimeter
  • Depth: 310 Millimeter


  • Radiological video camera patient positioning/tracking system
No Description
VISION RT LIMITED
AlignRT
Not in Commercial Distribution

  • B120ALIGNRT0 ()
AlignRT

  • Radiological video camera patient positioning/tracking system
ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter
Avanos Medical, Inc.
45082
In Commercial Distribution

  • 10193494450820 ()
  • 00193494450823 ()

  • Total Volume: 400 Milliliter
  • Fill Volume (ml)
PS6508-N

  • Cardiac pulse generator software
LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562914 ()


  • Cardiac pulse generator software
LATITUDE Consult™ System
BOSTON SCIENTIFIC CORPORATION
6294
In Commercial Distribution

  • 00802526562907 ()


  • Cardiac pulse generator software
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.3
In Commercial Distribution

  • 00856104006123 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.2
In Commercial Distribution

  • 00856104006079 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
2.1
In Commercial Distribution

  • 00856104006024 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
1.1
In Commercial Distribution

  • 00856104006017 ()


  • Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS INDIA SOFTWARE PRIVATE LIMITED
13.0
In Commercial Distribution

  • 00856104006000 ()


  • Radiation therapy treatment record/verify system
BD FACSDiva™ Software v 9.2
Becton, Dickinson And Company
665421
In Commercial Distribution

  • 00382906654212 ()
665421

  • Laboratory instrument/analyser application software IVD
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