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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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XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259100 ()
XSCRIBE-6GC-XXBXB

  • Cardiopulmonary stress exercise monitoring system computer
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00817655020860 ()
HSCRIBE-6AA-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 32M
Not in Commercial Distribution

  • 00850951007326 ()
061000-2000

  • Radiology picture archiving and communication system workstation
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 32L
Not in Commercial Distribution

  • 00850951007241 ()
061000-2000

  • Radiology picture archiving and communication system workstation
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 31K
Not in Commercial Distribution

  • 00850951007210 ()
061000-2000

  • Radiology picture archiving and communication system workstation
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 30K
Not in Commercial Distribution

  • 00850951007180 ()
061000-2000

  • Radiology picture archiving and communication system workstation
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 29K
Not in Commercial Distribution

  • 00850951007159 ()
061000-2000

  • Radiology picture archiving and communication system workstation
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 28K
Not in Commercial Distribution

  • 00850951007128 ()
061000-2000

  • Radiology picture archiving and communication system workstation
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 27K
Not in Commercial Distribution

  • 00850951007081 ()
061000-2000

  • Radiology picture archiving and communication system workstation
TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 25J
Not in Commercial Distribution

  • 00850951007012 ()
061000-2000

  • Radiology picture archiving and communication system workstation
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