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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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ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution

  • 05060878810052 ()


  • Ultrasound imaging system application software
ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution

  • 05060878810021 ()


  • Ultrasound imaging system application software
The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set. Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution

  • 05060508110002 ()


  • Angiographic x-ray system application software
X EP System Averaged Impedance Drop Software License
ST. JUDE MEDICAL, INC.
ENSITE-IMP-01
In Commercial Distribution

  • 05415067048400 ()
ENSITE-IMP-01

  • Cardiac mapping system application software
X EP System EnSite VoXel Flex Mode Software License
ST. JUDE MEDICAL, INC.
ENSITE-FLEX-01
In Commercial Distribution

  • 05415067048394 ()
ENSITE-FLEX-01

  • Cardiac mapping system application software
X EP System LiveSync Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LS-01
In Commercial Distribution

  • 05415067048387 ()
ENSITE-D-LS-01

  • Cardiac mapping system application software
X EP System Averaged Impedance Drop Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-IMP-01
In Commercial Distribution

  • 05415067048370 ()
ENSITE-D-IMP-01

  • Cardiac mapping system application software
X EP System AutoMark Distance Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AMD-01
In Commercial Distribution

  • 05415067048363 ()
ENSITE-D-AMD-01

  • Cardiac mapping system application software
X EP System EnSite VoXel Flex Mode Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FLEX-01
In Commercial Distribution

  • 05415067048356 ()
ENSITE-D-FLEX-01

  • Cardiac mapping system application software
X EP System LiveSync Software License
ST. JUDE MEDICAL, INC.
ENSITE-LS-01
In Commercial Distribution

  • 05415067048349 ()
ENSITE-LS-01

  • Cardiac mapping system application software
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