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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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EVA SELECT - D83399924121050

EVA SELECT SIZE 1 SENSOR
ImageWorks
9992412105
In Commercial Distribution

  • D83399924121050 ()
9992412105

  • General-purpose dental x-ray system application software

Progeny imaging Domestic - 00841709105661

Progeny Imaging Software
MIDMARK CORPORATION
500-427
In Commercial Distribution

  • 00841709105661 ()
500-427

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101410

X-ray system application software
MIDMARK CORPORATION
60-A0007
In Commercial Distribution

  • 00841709101410 ()
60-A0007

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101403

X-ray system application software
MIDMARK CORPORATION
60-A0004
In Commercial Distribution

  • 00841709101403 ()
60-A0004

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101397

X-ray system application software
MIDMARK CORPORATION
60-A0003
In Commercial Distribution

  • 00841709101397 ()
60-A0003

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101380

X-ray system application software
MIDMARK CORPORATION
45-A0023
In Commercial Distribution

  • 00841709101380 ()
45-A0023

  • General-purpose dental x-ray system application software

Midmark Progeny Imaging Software - 00841709101373

X-ray system application software
MIDMARK CORPORATION
30-A0027
In Commercial Distribution

  • 00841709101373 ()
30-A0027

  • General-purpose dental x-ray system application software

StrokeSENS - B926SSSX10

StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution

  • B926SSSX10 ()


  • CT system application software

DRGEM - 08800011120351

400V3~/125kV
DRGEM Corporation
FDR Smart FGXR-32S
In Commercial Distribution

  • 08800011120351 ()


  • Stationary basic diagnostic x-ray system, analogue

DRGEM - 08800011120344

220~230V~/125kV
DRGEM Corporation
FDR Smart FGXR-32S
In Commercial Distribution

  • 08800011120344 ()


  • Stationary basic diagnostic x-ray system, analogue
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