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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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Ultrasound system, imaging, general-purpose, portable
TELEMED UAB
EXT-3M
In Commercial Distribution

  • 04772057000161 ()


  • General-purpose ultrasound imaging system
Ultrasound system, imaging, general-purpose, portable
TELEMED UAB
EXT-1M
In Commercial Distribution

  • 04772057000154 ()


  • General-purpose ultrasound imaging system
Ultrasound system, imaging, general-purpose, portable
TELEMED UAB
EXT-1H
In Commercial Distribution

  • 04772057000109 ()


  • General-purpose ultrasound imaging system
I-STREME ECHO ULTRASOUND SYSTEM with Linear Array Probe
INTERSON CORP
1
In Commercial Distribution

  • 00850921007219 ()


  • 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
The 1300 Ultrasound Scanner is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. It includes the following scanning modes: B, B+M, B+D, B+C, B+D+C . (D is PWD, C is Color Flow mapping Doppler including Velocity and Variance display, Amplitude(power)Doppler including directional display ). B mode includes Tissue Harmonic Imaging , VFI (Vector Flow Imaging), Elastography, Contrast Imaging, CW doppler. The system performs simple geometric measurements and calculations in the following areas: Urology, Vascular, Cardiology, OB/GYN, Emergency Medicine, Surgery, and Anesthesia. Optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
Bk Medical ApS
1300
In Commercial Distribution

  • 05704916001285 ()
1300

  • General-purpose ultrasound imaging system
Mobile Touch Dock with battery. Includes Power Cable Holder
Bk Medical ApS
UA1814
Not in Commercial Distribution

  • 05704916001087 ()


  • General-purpose ultrasound imaging system
Mobile Touch Dock with backpack
Bk Medical ApS
UA1810
Not in Commercial Distribution

  • 05704916001070 ()


  • General-purpose ultrasound imaging system
Keyboard Table Dock
Bk Medical ApS
UA1283
Not in Commercial Distribution

  • 05704916001063 ()


  • General-purpose ultrasound imaging system
Mobile Keyboard Dock with backpack and battery. Includes Power Cable Holder
Bk Medical ApS
UA1214
Not in Commercial Distribution

  • 05704916001056 ()


  • General-purpose ultrasound imaging system
Mobile Keyboard Dock with backpack
Bk Medical ApS
UA1210
Not in Commercial Distribution

  • 05704916001049 ()


  • General-purpose ultrasound imaging system
Ultrasound scanner 2202 supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can guide biopsy- and puncture needles. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive purpose.
Bk Medical ApS
2202
Not in Commercial Distribution

  • 05704916001032 ()


  • General-purpose ultrasound imaging system
Ultrasound scanner 1202 and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
Bk Medical ApS
1202
In Commercial Distribution

  • 05704916001025 ()


  • General-purpose ultrasound imaging system
ULTRASOUND SYSTEM
Bk Medical ApS
2300
In Commercial Distribution

  • 05704916000264 ()


  • General-purpose ultrasound imaging system
The TargetScan Touch® Transrectal Ultrasound System images the prostate. From the image, the system can construct a biopsy or treatment plan displayed as an overlay, or target, on the ultrasound image. In conjunction with the planned locations, accessory mechanical guides are used to position biopsy and treatment devices.
Best Nomos
001-A100
In Commercial Distribution

  • 00852656007069 ()


  • General-purpose ultrasound imaging system
The Sonalis Ultrasound System is a real time, two dimensional, diagnostic ultrasound system which produces high quality images through user friendly operation. The system currently supports imaging applications for trans-rectal ultrasound imaging.
Best Nomos
209876
In Commercial Distribution

  • 00852656007014 ()


  • General-purpose ultrasound imaging system
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
The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 FV667A
In Commercial Distribution

  • 04547410332377 ()


  • General-purpose ultrasound imaging system
The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 PLATINUM FV666A
In Commercial Distribution

  • 04547410332360 ()


  • General-purpose ultrasound imaging system
The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 FV652A
In Commercial Distribution

  • 04547410332353 ()


  • General-purpose ultrasound imaging system
The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 PLATINUM FV651A
In Commercial Distribution

  • 04547410332346 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Resona A MV
In Commercial Distribution

  • 06903053042161 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho R9 Super
In Commercial Distribution

  • 06903053040822 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho R9T
In Commercial Distribution

  • 06903053040792 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho R9S
In Commercial Distribution

  • 06903053040785 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho R9 Exp
In Commercial Distribution

  • 06903053040778 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho R9 Pro
In Commercial Distribution

  • 06903053040761 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho R9
In Commercial Distribution

  • 06903053040754 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho R9W
In Commercial Distribution

  • 06903053040747 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
TE Air
In Commercial Distribution

  • 06903053035132 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
VMM-ICE-01
In Commercial Distribution

  • 06903053033343 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Resona N9
In Commercial Distribution

  • 06903053013154 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Recho N9
In Commercial Distribution

  • 06903053013116 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Nuewa N9
In Commercial Distribution

  • 06903053013079 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Consona Nova
In Commercial Distribution

  • 06903053013062 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Consona NT
In Commercial Distribution

  • 06903053013048 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Consona NI
In Commercial Distribution

  • 06903053013031 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Consona N9T
In Commercial Distribution

  • 06903053013000 ()


  • General-purpose ultrasound imaging system
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