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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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
AMIMON LTD
MD52 Rx - MDWL2_B3P1RX
In Commercial Distribution

  • 00817157020825 ()


  • Medical image management system
No Description
AMIMON LTD
MD52 Tx - MDWL2_B1P1TX
In Commercial Distribution

  • 00817157020818 ()


  • Medical image management system
No Description
AMIMON LTD
MD11 System - MDWL1_B1N1RX
In Commercial Distribution

  • 00817157020771 ()


  • Medical image management system
No Description
AMIMON LTD
MD11 System - MDWL1_C1N1TX
In Commercial Distribution

  • 00817157020764 ()


  • Medical image management system
No Description
AMIMON LTD
MD62 System - MDWL2_B1J1RX
In Commercial Distribution

  • 00817157020757 ()


  • Medical image management system
No Description
AMIMON LTD
MD62 System - MDWL2_B1J1TX
In Commercial Distribution

  • 00817157020740 ()


  • Medical image management system
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
SYNERGYHD3 DICOM KEY
ARTHREX, INC.
AR-3200-1020
In Commercial Distribution

  • 00888867100619 ()
AR-3200-1020

  • Medical image management system
No Description
Sleepiz AG
1.0
In Commercial Distribution

  • 07649996477019 ()


  • Multiple vital physiological parameter monitoring system, home-use
Synergy Matrix Management SW Addtnl Lic
ARTHREX, INC.
AR-3200-1049
In Commercial Distribution

  • 00888867261648 ()
AR-3200-1049

  • Medical image management system
BioOptico Spectral Mode Key Kit
ARTHREX, INC.
AR-3200-1026
In Commercial Distribution

  • 00888867387928 ()
AR-3200-1026

  • Medical image management system
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max15
In Commercial Distribution

  • B510PMMAX15 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
CMS-2000
In Commercial Distribution

  • B510CMS20001 ()


  • Centralized patient monitor
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max13
In Commercial Distribution

  • B510PMMAX13 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-200M PRO
In Commercial Distribution

  • B510PM200MPRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL PRO
In Commercial Distribution

  • B510PM2000XLPRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL PLUS
In Commercial Distribution

  • B510PM2000XLPLUS1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL
In Commercial Distribution

  • B510PM2000XL1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000M
In Commercial Distribution

  • B510PM2000M1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000A PRO
In Commercial Distribution

  • B510PM2000APRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000A
In Commercial Distribution

  • B510PM2000A1 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ADVANCED INSTRUMENTATIONS, INC.
CMS-1000FM
In Commercial Distribution

  • B510CMS1000FM1 ()


  • Centralized patient monitor
No Description
ICU MEDICAL, INC.
3304
In Commercial Distribution

  • 10610586036347 ()


  • Multiple vital physiological parameter monitoring system, clinical
Synergy.Net Text Notification License K
ARTHREX, INC.
AR-3200-1046
In Commercial Distribution

  • 00888867200319 ()
AR-3200-1046

  • Medical image management system
Synergy.Net Reporting License Key
ARTHREX, INC.
AR-3200-1045
In Commercial Distribution

  • 00888867200302 ()
AR-3200-1045

  • Medical image management system
Synergy.Net OR Command License Key
ARTHREX, INC.
AR-3200-1044
In Commercial Distribution

  • 00888867200296 ()
AR-3200-1044

  • Medical image management system
Synergy.net Printing License Key
ARTHREX, INC.
AR-3200-1043
In Commercial Distribution

  • 00888867200289 ()
AR-3200-1043

  • Medical image management system
No Description
Haag-Streit AG
i9.0
In Commercial Distribution

  • 07640132987256 ()


  • Medical image management system
No Description
Haag-Streit AG
i8.2
In Commercial Distribution

  • 07640132986105 ()


  • Medical image management system
Monitor with DOX SPO2, NIBP, and HR
CRITICARE TECHNOLOGIES, INC.
eQuality 506DN
In Commercial Distribution

  • B438560DNUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNVP3
In Commercial Distribution

  • B438506LNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with Nellcor SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNP3
In Commercial Distribution

  • B438506LNP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with DOX SPO2, NIBP, HR, Printer and Temp
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNVP3
In Commercial Distribution

  • B438506DNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with DOX SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506DNP3
In Commercial Distribution

  • B438506DNP3US0 ()


  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034040 ()
500-0034-04

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034030 ()
500-0034-03

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034020 ()
500-0034-02

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034010 ()
500-0034-01

  • Multiple vital physiological parameter monitoring system, clinical
Athena GTX Device Management Suite - Android
ATHENA GTX, INC.
ADMS Android Software
In Commercial Distribution

  • B3943950010000 ()
395-0010-00

  • Centralized patient monitor
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
WVSM Management Suite - iOS
ATHENA GTX, INC.
iOS Software
In Commercial Distribution

  • B3943950006000 ()
395-0006-00

  • Centralized patient monitor
Athena GTX Device Management Suite - PC
ATHENA GTX, INC.
ADMS PC Software
In Commercial Distribution

  • B3943900008000 ()
390-0008-00

  • Centralized patient monitor
WVSM Management Suite - PC
ATHENA GTX, INC.
PC Software
In Commercial Distribution

  • B3943900004000 ()
390-0004-00

  • Centralized patient monitor
Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software
This is a portable digital diagnostic x-ray system Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)
SEDECAL
SPSLW4
In Commercial Distribution

  • 08436046001862 ()


  • Portable basic diagnostic x-ray system, digital
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
SEDECAL
SPSL8HC
In Commercial Distribution

  • 08436046001893 ()


  • Portable basic diagnostic x-ray system, digital
This Portable Diagnostic Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest,abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography).
SEDECAL
SPSL4HC
In Commercial Distribution

  • 08436046001886 ()


  • Portable basic diagnostic x-ray system, digital
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