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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 GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


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

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software
No Description
Prenosis, Inc.
1.5.0
In Commercial Distribution

  • 00860013516208 ()


  • Clinical management support software IVD
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
ZS3 - SP Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
ZS3-SP
Not in Commercial Distribution

  • 00851315007211 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
Z.One PRO
Not in Commercial Distribution

  • 00851315007013 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System
ZONARE MEDICAL SYSTEMS, INC.
ZS3
Not in Commercial Distribution

  • 00851315007006 ()


  • 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
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee 1000
In Commercial Distribution

  • 06938396410001 ()


  • General-purpose ultrasound imaging system
Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
CTS-485
In Commercial Distribution

  • 06938396404857 ()


  • General-purpose ultrasound imaging system
Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
CTS-415
In Commercial Distribution

  • 06938396404154 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee U5
In Commercial Distribution

  • 06938396401443 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee U3
In Commercial Distribution

  • 06938396401436 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee U2
In Commercial Distribution

  • 06938396401429 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee U1
In Commercial Distribution

  • 06938396401412 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee K5
In Commercial Distribution

  • 06938396401405 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee K3
In Commercial Distribution

  • 06938396401399 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee K2
In Commercial Distribution

  • 06938396401382 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee K1
In Commercial Distribution

  • 06938396401375 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee C5
In Commercial Distribution

  • 06938396401368 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee C3
In Commercial Distribution

  • 06938396401351 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee C2
In Commercial Distribution

  • 06938396401344 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Apogee C1
In Commercial Distribution

  • 06938396401337 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius C3
In Commercial Distribution

  • 06938396401078 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius C6
In Commercial Distribution

  • 06938396401061 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius V5
In Commercial Distribution

  • 06938396401054 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius V6
In Commercial Distribution

  • 06938396401047 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius P3
In Commercial Distribution

  • 06938396401030 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius P5
In Commercial Distribution

  • 06938396401023 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius P8
In Commercial Distribution

  • 06938396401016 ()


  • General-purpose ultrasound imaging system
Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
Readius L5
In Commercial Distribution

  • 06938396400996 ()


  • General-purpose ultrasound imaging system
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