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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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Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
ZS3
Not in Commercial Distribution

  • 00851315007006 ()


  • General-purpose ultrasound imaging system
No Description
Prenosis, Inc.
1.5.0
In Commercial Distribution

  • 00860013516208 ()


  • Clinical management support software IVD
Linear probe.
Norland at Swissray
uREzpocus L
In Commercial Distribution

  • 00866955000492 ()


  • General-purpose ultrasound imaging system
Convex probe.
Norland at Swissray
uREzpocus C
In Commercial Distribution

  • 00866955000485 ()


  • General-purpose ultrasound imaging system
Ultrasonic pulsed doppler imaging system - MicroConvex array
Norland at Swissray
uREzpocus M
In Commercial Distribution

  • 00860008461223 ()


  • General-purpose ultrasound imaging system
Ultrasonic pulsed doppler imaging system - uREzpocus H
Norland at Swissray
uREzpocus H
In Commercial Distribution

  • 00860008461216 ()


  • General-purpose ultrasound imaging system
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082601 ()


  • MRI image interpretive software
Catalyst Ultrasound System -Portable
Halo Medical Technologies, LLC
HMT MCP
In Commercial Distribution

  • 00860008657886 ()


  • General-purpose ultrasound imaging system
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