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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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Novadaq Technologies Inc
SQ3500
In Commercial Distribution

  • 00858701006018 ()


  • Angiographic x-ray 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
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
Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software
Software for biopsy needle guide planning and tracking.
Medical Targeting Technologies GmbH
3
In Commercial Distribution

  • 04260476810015 ()


  • Brachytherapy system application software
Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software
Venue Sprint R5 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278754011 ()


  • Ultrasound imaging system application software
DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
GE HEALTHCARE
with Remote scanning for MR
In Commercial Distribution

  • 00195278707741 ()
5941611

  • MRI system application software
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