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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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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
Curved Array Probe
Halo Medical Technologies, LLC
HMT-SURM
In Commercial Distribution

  • 00860008657381 ()


  • General-purpose ultrasound imaging system
Catalyst Ultrasound System - Conventional
Halo Medical Technologies, LLC
HMT-LTSYS
In Commercial Distribution

  • 00860008657312 ()


  • General-purpose ultrasound imaging system
Catalyst Ultrasound System -Portable
Halo Medical Technologies, LLC
HMT-AIOSYS
In Commercial Distribution

  • 00860008657305 ()


  • 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
Ultrasonic pulsed doppler imaging system - Convex HD array
Norland at Swissray
uREzpocus C-EMS
In Commercial Distribution

  • 00860008461209 ()


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

  • 00860013516208 ()


  • Clinical management support software IVD
No Description
VERATHON INC
i10™
In Commercial Distribution

  • 10879123008234 ()
  • 00879123008237 ()
E570-0413

  • General-purpose ultrasound imaging system
No Description
VERATHON INC
i10™
In Commercial Distribution

  • 00879123007445 ()
0570-0413

  • General-purpose ultrasound imaging system
SonoVision Ultrasound Imaging Console
Tissue Differentiation Intelligence LLC
100009
In Commercial Distribution

  • 00860001239355 ()


  • General-purpose ultrasound imaging system
A devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is a mobile assembly which support a wide variety of transducers and related application software packages.
LINKQUEST INC.
Model SQ860
In Commercial Distribution

  • 00860000784801 ()


  • General-purpose ultrasound imaging system
Color Doppler Ultrasound Diagnostic System
Contec Medical Systems Co., Ltd.
CMS1700C
In Commercial Distribution

  • 06945040106913 ()


  • General-purpose ultrasound imaging system
Color Doppler Ultrasound Diagnostic System
Contec Medical Systems Co., Ltd.
CMS1700B
In Commercial Distribution

  • 06945040106593 ()


  • General-purpose ultrasound imaging system
B-Ultrasound Diagnostic System
Contec Medical Systems Co., Ltd.
CMS600P2PLUS
In Commercial Distribution

  • 06945040106555 ()


  • General-purpose ultrasound imaging system
B-Ultrasound Diagnostic System
Contec Medical Systems Co., Ltd.
CMS600P2
In Commercial Distribution

  • 06945040101161 ()


  • General-purpose ultrasound imaging system
Affiniti CVx Diagnostic Ultrasound System Circular Edition
Philips Ultrasound LLC
795407
In Commercial Distribution

  • 00884838126947 ()


  • General-purpose ultrasound imaging system
EPIQ CVxi Diagnostic Ultrasound System
Philips Ultrasound LLC
795232
In Commercial Distribution

  • 00884838126930 ()


  • General-purpose ultrasound imaging system
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