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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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IMAGE DIAGNOSTICS, INC. - 00850977007461

IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 26IN. MONITORS,PREVIEW DISPLAY,MDS,120V,#A280-0330
IMAGE DIAGNOSTICS, INC.
MDS, 120V
Not in Commercial Distribution

  • 00850977007461 ()
A280-0330

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS INC - 00850977007454

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 32IN. MONITOR,FIXED,ILEX32,#A280-0630 OR #A280-0821 FOR THE 4K VERSION
IMAGE DIAGNOSTICS, INC.
ilex32
In Commercial Distribution

  • 00850977007454 ()
A280-0630 & A280-0821

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007447

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,230V,#A280-0781
IMAGE DIAGNOSTICS, INC.
ilex55, 230V
In Commercial Distribution

  • 00850977007447 ()
A280-0781

  • Diagnostic x-ray digital imaging system workstation

IMAGE DIAGNOSTICS, INC - 00850977007430

IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 55IN. MONITOR,TELESCOPIC,ILEX W/IPS500A,120V,#A280-0600 OR W/IPS1000A #A280-0700
IMAGE DIAGNOSTICS, INC.
ilex55, 120V
In Commercial Distribution

  • 00850977007430 ()
A280-0600 OR A280-0700

  • Diagnostic x-ray digital imaging system workstation

Clinic Laptop - 00860003118382

No Description
Canary Medical USA LLC
43-5570-003-15
In Commercial Distribution

  • 00860003118382 ()


  • Patient health record information system

OR Laptop - 00860003118337

Dedicated Laptop PC, part of the OR Base Station System
Canary Medical USA LLC
43-5570-003-14
In Commercial Distribution

  • 00860003118337 ()


  • Patient health record information system

Senolris - 00840682104395

SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation

CENTRICITY - 00840682102681

MD CPN 6.96 MEDICAL DEVICE
GE HEALTHCARE
PERINATAL6.96
Not in Commercial Distribution

  • 00840682102681 ()


  • Patient health record information system

Centricity - 00840682123785

MD CPN 6.97 MEDICAL DEVICE
GE HEALTHCARE
Perinatal6.97
Not in Commercial Distribution

  • 00840682123785 ()


  • Patient health record information system

AXIR-CX - 08800099500076

Radiological Image Processing System
Radisen Co., Ltd.
AXIR-CX
In Commercial Distribution

  • 08800099500076 ()
AXIR-CX

  • Diagnostic x-ray digital imaging system workstation
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