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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StarGuide NM GANTRY MDR FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911BJ
In Commercial Distribution

  • 00195278755544 ()
5842898-10

  • Stationary gamma camera system
  • Full-body CT system
Spectral Bone Marrow MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278630377 ()
5929650

  • CT system application software
OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
G E MEDICAL SYSTEMS ISRAEL LTD.
Legend
In Commercial Distribution

  • 00195278592309 ()


  • Full-body CT system
  • PET system
Spine Auto Views Medical Device
GE MEDICAL SYSTEMS
See CODE part
In Commercial Distribution

  • 00195278534064 ()


  • CT system application software
STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution

  • 00195278118295 ()


  • Stationary gamma camera system
  • Full-body CT system
PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make
GE MEDICAL SYSTEMS, INC.
MI
In Commercial Distribution

  • 00195278098603 ()


  • Full-body CT system
  • PET system
No Description
Siemens Healthcare GmbH
11665780
In Commercial Distribution

  • 04056869996172 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11665409
Not in Commercial Distribution

  • 04056869964331 ()


  • CT system application software
No Description
Siemens Healthcare GmbH
11583323
In Commercial Distribution

  • 04056869297279 ()


  • CT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
Bigraph Vision Quadra
In Commercial Distribution

  • 04056869269429 ()


  • PET/CT system
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