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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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No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-052709-00
In Commercial Distribution

  • 06936415902803 ()


  • General-purpose ultrasound imaging system
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-053651-00
In Commercial Distribution

  • 06936415902629 ()


  • General-purpose ultrasound imaging system
1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-phase, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions
MYCARDIUM AI LIMITED
010002
In Commercial Distribution

  • 05061038730036 ()
1CMR Pro

  • MRI image interpretive software
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
Ultrasound Console
ST. JUDE MEDICAL, INC.
H701336
In Commercial Distribution

  • 05415067013361 ()
H701336

  • 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
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
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