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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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Tracker Sleeve
Stryker Leibinger GmbH & Co. KG
6000-803-000
In Commercial Distribution

  • 07613327467215 ()
6000-803-000

  • Surgical planning/navigation-enhancement system
Precision Targeting Guide
Stryker Leibinger GmbH & Co. KG
6000-802-000
In Commercial Distribution

  • 07613327467208 ()
6000-802-000

  • Surgical planning/navigation-enhancement system
LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist the trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (patient visit). A trained operator places circular regions of interest drawn upon previously acquired MR images, from which a summary report is generated. The summary report is sent to an interpreting clinician. LiverMultiScan does not replace the usual procedures for assessment of the liver by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed. The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients will present with clinical symptoms or risk factors which may indicate liver disease. Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics are to provide imaging information to assist in characterising tissue in the liver, which is additional to existing methods for obtaining information relating to the liver. LiverMultiScan metrics do not replace any existing diagnostic source of information, but can be used to identify patients who may benefit most from further evaluation, including biopsy. Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision.
PERSPECTUM LTD
2.0
In Commercial Distribution

  • B554LMS2000 ()


  • MRI system application software
No Description
Sleepiz AG
1.0
In Commercial Distribution

  • 07649996477019 ()


  • Multiple vital physiological parameter monitoring system, home-use
Portable X-Ray System-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR301
In Commercial Distribution

  • 00817100020353 ()


  • Portable basic diagnostic x-ray system, digital
SR-130 + DR Portable VIZION M portavle X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR310
In Commercial Distribution

  • 00817100020124 ()


  • Portable basic diagnostic x-ray system, digital
SR-130 + DR Portable X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR300
In Commercial Distribution

  • 00817100020117 ()


  • Portable basic diagnostic x-ray system, digital
No Description
ICU MEDICAL, INC.
3304
In Commercial Distribution

  • 10610586036347 ()


  • Multiple vital physiological parameter monitoring system, clinical
X-Guide 3.7.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421023361 ()


  • Surgical planning/navigation-enhancement system
X-Guide 3.6.0 Linux Software (MDR)
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022920 ()


  • Surgical planning/navigation-enhancement system
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