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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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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
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
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