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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Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094312744 ()
QS-6CC-DDBAC

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094312720 ()
QS-6CC-DEBAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094312713 ()
QS-6CC-DEBAC

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094312706 ()
QS-6FC-DDBAA

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer(includes 2 starter packs of full-grid paper - A4), Q- Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with 43 in. leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263497 ()
QS-6CC-DFCAX

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; International power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q- Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with 25" leadwires with pinch for AM12Q; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094312737 ()
QS-6CC-DEBAA

  • Cardiopulmonary stress exercise monitoring system computer
Provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. The Lung Lobe Quantification module in Hybrid3D introduces an efficient and automated workflow solution to compute 3D lobar anatomy from CT (with or without contrast). Functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) can also be include in the analysis to relate lobar anatomy to function.
Hermes Medical Solutions AB
1.0
Not in Commercial Distribution

  • 00859873006042 ()
P54

  • Nuclear medicine system workstation
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; International power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; IEC 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DI
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355222 ()
QS-6ED-DGEAB

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress 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; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; No power cord; No printer, Q- Stress basic laser transport cart with keyboard tray; AHA 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + X
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094307818 ()
QS-6IA-XGDAA

  • Cardiopulmonary stress exercise monitoring system computer
Provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations. The Lung Lobe Quantification module in Hybrid3D introduces an efficient and automated workflow solution to compute 3D lobar anatomy from CT (with or without contrast). Functional images (SPECT V/Q, SUV SPECT, CT iodine maps, hyperpolarized xenon MRI, etc.) can also be include in the analysis to relate lobar anatomy to function. UDI = 00859873006073 applies to Hybrid 3D version 2.x and 3.x.
Hermes Medical Solutions AB
2.2 and 3.0
In Commercial Distribution

  • 00859873006073 ()
P54

  • Nuclear medicine system workstation
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