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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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The Surgical Light Control and Surgical Camera Control for the Harmony IQ 2800 Integration Systems promotes efficient and prompt reaction to procedure events.
BLACK DIAMOND VIDEO, INC.
Harmony iQ 2800
Not in Commercial Distribution

  • 00724995199135 ()
RLQ2000SLC

  • Operating room audiovisual data/device management system application software
The HexaVue Surgical Camera Control OR Integration software module allows the remote control of surgical camera.
BLACK DIAMOND VIDEO, INC.
HexaVue SCC 1.0
In Commercial Distribution

  • 00724995198503 ()
XQHILCC1

  • Operating room audiovisual data/device management system application software
The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals.
BLACK DIAMOND VIDEO, INC.
HexaVue-SLC 1.0
In Commercial Distribution

  • 00724995198497 ()
XQHLC1

  • Operating room audiovisual data/device management system application software
The IDSS Integration System with Surgical Camera Control is an integrated audio-visual system which combines monitors, medical imaging devices, lights, music, and cameras.
BLACK DIAMOND VIDEO, INC.
IDSS-SCC
Not in Commercial Distribution

  • 00724995198473 ()
XQSILCC1

  • Operating room audiovisual data/device management system application software
ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS). ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.0
In Commercial Distribution

  • 05060496770066 ()


  • Laboratory instrument/analyser application software IVD
FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo. The software application is a measuring medical device intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients. The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management. FerriSmart is indicated to: • measure liver iron concentration in individuals with confirmed or suspected systemic iron overload • monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v01
In Commercial Distribution

  • 09369998038619 ()


  • MRI system application software
No Description
ECHOIQ LIMITED
1.5.0
In Commercial Distribution

  • 09309001128005 ()


  • Cardiovascular interpretive screening software
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution

  • 09353278000823 ()


  • Ultrasound imaging system application software
The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Fifth Eye, Inc.
2
In Commercial Distribution

  • B823AHIV200 ()


  • Clinical management support software
Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
Fifth Eye, Inc.
P1
In Commercial Distribution

  • B823AHIP100 ()


  • Clinical management support software
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