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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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uREzpocus - 00860008461223

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

  • 00860008461223 ()


  • General-purpose ultrasound imaging system

uREzpocus - 00860008461216

Ultrasonic pulsed doppler imaging system - uREzpocus H
Norland at Swissray
uREzpocus H
In Commercial Distribution

  • 00860008461216 ()


  • General-purpose ultrasound imaging system

uREzpocus - 00860008461209

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

  • 00860008461209 ()


  • General-purpose ultrasound imaging system

Bot Image, Inc. - 00860009082618

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

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software

Sepsis ImmunoScore - 00860013516208

No Description
Prenosis, Inc.
1.5.0
In Commercial Distribution

  • 00860013516208 ()


  • Clinical management support software IVD

QT Scanner 2000 - 00852619008003

The QT Scanner 2000 Model A is an automated and software-controlled ultrasound system for breast imaging that can be operated by a single operator. The system consists of an examination table, a scan tank, image processing electronics, operator console, breast retention device, and ultrasound beam forming electronics. The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
Qt Imaging, Inc.
A
In Commercial Distribution

  • 00852619008003 ()
100366

  • General-purpose ultrasound imaging system

Ultrasound System, ZS3 - 00851315007211

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

  • 00851315007211 ()


  • General-purpose ultrasound imaging system

Ultrasound System, Z.One PRO - 00851315007013

Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
Z.One PRO
Not in Commercial Distribution

  • 00851315007013 ()


  • General-purpose ultrasound imaging system

Ultrasound System, ZS3 - 00851315007006

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

  • 00851315007006 ()


  • General-purpose ultrasound imaging system

SonoVision - 00860001239355

SonoVision Ultrasound Imaging Console
Tissue Differentiation Intelligence LLC
100009
In Commercial Distribution

  • 00860001239355 ()


  • General-purpose ultrasound imaging system
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