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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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Spacelabs Healthcare - 10841522104947

KIT,START UP KIT UPGRADE,SKIN TEMP SENSOR
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104947 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522104930

KIT,START UP KIT UPGRADE,5-L ECG AAMI
SPACELABS HEALTHCARE (WASHINGTON), INC
93300
Not in Commercial Distribution

  • 10841522104930 ()
N/A

  • Multiple vital physiological parameter monitoring system, clinical

qube - 10841522100574

COMPACT MONITOR, 91390, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube
In Commercial Distribution

  • 10841522100574 ()
R-91390

  • Multiple vital physiological parameter monitoring system, clinical

qube - 10841522100550

COMPACT MONITOR,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
91390
Not in Commercial Distribution

  • 10841522100550 ()
91390

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522100536

DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522100536 ()
011-0241-01

  • Centralized patient monitor

qube mini - 10841522100239

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
Not in Commercial Distribution

  • 10841522100239 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522100222

Remote Display Controller
SPACELABS HEALTHCARE (WASHINGTON), INC
91388
In Commercial Distribution

  • 10841522100222 ()
N/A

  • Centralized patient monitor

Xhibit - 10841522100345

XHIBIT CENTRAL STATION,96102
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522100345 ()
96102

  • Centralized patient monitor

Spacelabs Healthcare - 10841522128479

OPTION,SPACELABS SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Elance
In Commercial Distribution

  • 10841522128479 ()
93300-S

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522128462

OPTION,NELLCOR OXIMAX SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Elance
In Commercial Distribution

  • 10841522128462 ()
93300-N

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522128455

OPTION, MASIMO SET SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Elance
In Commercial Distribution

  • 10841522128455 ()
93300-M

  • Multiple vital physiological parameter monitoring system, clinical

Qube Mini - 10841522127328

KIT,UPGR,WIRELESS (OPT P),OLD 670-1712-00,91389
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
In Commercial Distribution

  • 10841522127328 ()
040-1758-00

  • Multiple vital physiological parameter monitoring system, clinical

Qube Mini - 10841522127311

KIT,UPGRADE,WIRELESS (OPT P) OLD DISPLAY,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Compact Monitor
In Commercial Distribution

  • 10841522127311 ()
040-1731-00

  • Multiple vital physiological parameter monitoring system, clinical

Qube Mini - 10841522127304

KIT,UPGRADE,WIRELESS (OPTION P),MONITORS
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Compact Monitor
In Commercial Distribution

  • 10841522127304 ()
040-1730-00

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522127069

XHIBIT CENTRAL STATION,96102
SPACELABS HEALTHCARE (WASHINGTON), INC
Xhibit Central
In Commercial Distribution

  • 10841522127069 ()
96102

  • Centralized patient monitor

Ultraview SL® - 10841522125997

KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultraview
In Commercial Distribution

  • 10841522125997 ()
040-1640-02

  • Multiple vital physiological parameter monitoring system, clinical

Ultraview SL® - 10841522125980

KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultraview
In Commercial Distribution

  • 10841522125980 ()
040-1640-03

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522122996

96501,XHIBIT XC4
SPACELABS HEALTHCARE (WASHINGTON), INC
Xhibit XC4
In Commercial Distribution

  • 10841522122996 ()
96501

  • Centralized patient monitor

UltraviewSL - 10841522102981

KIT, DM3 UPDATE, V1.8
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102981 ()
V1.8

  • Multiple vital physiological parameter monitoring system, clinical

UltraviewSL - 10841522102974

KIT, DM3 UPDATE, V1.7
SPACELABS HEALTHCARE (WASHINGTON), INC
91330
Not in Commercial Distribution

  • 10841522102974 ()
V1.7

  • Multiple vital physiological parameter monitoring system, clinical

CARTO 3 - 10846835000870

CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

  • Cardiac mapping system

Vmax - 10846446032918

SWR KIT CARDIOSOFT V6.73
Carefusion Corporation
28282-001
Not in Commercial Distribution

  • 10846446032918 ()
28282-001

  • Cardiac mapping system

Vmax - 10846446032901

SWR PKG CARDIOSOFT V6.73
Carefusion Corporation
28281-001
Not in Commercial Distribution

  • 10846446032901 ()
28281-001

  • Cardiac mapping system

Vmax - 10846446032888

CARDIOSOFT V6.73 CAM14 W/USB
Carefusion Corporation
28278-001
Not in Commercial Distribution

  • 10846446032888 ()
28278-001

  • Cardiac mapping system

RHYTHMIA HDx™ - 00191506020804

Ablation Connection Box (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA65010
In Commercial Distribution

  • 00191506020804 ()
M004RA65010

  • Cardiac mapping system

RHYTHMIA HDx™ - 00191506020798

Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™)
BOSTON SCIENTIFIC CORPORATION
M004RA63020
In Commercial Distribution

  • 00191506020798 ()
M004RA63020

  • Cardiac mapping system

OPAL HDx™ - 00191506055370

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004OPLINSTALL2EN0
In Commercial Distribution

  • 00191506055370 ()
M004OPLINSTALL2EN0

  • Cardiac mapping system

OPAL HDx™ - 00191506055325

Mapping System Signal Station
BOSTON SCIENTIFIC CORPORATION
M004OPAL10200
In Commercial Distribution

  • 00191506055325 ()
M004OPAL10200

  • Cardiac mapping system

OPAL HDx™ - 00191506055301

Mapping System Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004OPAL40100
In Commercial Distribution

  • 00191506055301 ()
M004OPAL40100

  • Cardiac mapping system

RHYTHMIA HDx™ - 00191506034429

Ablation Connection Box
BOSTON SCIENTIFIC CORPORATION
M004RA6301US0
In Commercial Distribution

  • 00191506034429 ()
M004RA6301US0

  • Cardiac mapping system

SyMRI - 07340024700078

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. SyMRI can also generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, output from SyMRI can provide information useful in determining diagnosis. SyMRI 2D is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR). T1W and T2W images from SyMRI 3D may replace conventional MR images in a clinical setting when interpreting together with a conventional 3D T2W FLAIR image.
SyntheticMR AB (publ)
15
In Commercial Distribution

  • 07340024700078 ()


  • MRI system application software

SyMRI - 07340024700030

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME images. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
11
In Commercial Distribution

  • 07340024700030 ()


  • MRI system application software

Segment CMR - 07350010100027

Software for cardiac image analysis.
Medviso AB
2
In Commercial Distribution

  • 07350010100027 ()


  • MRI system application software

SyMRI - 07340024700061

SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from supported MR sequences to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI is intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from SyMRI. When interpreted by a trained physician, the parametric maps, tissue maps, and volumetrics from SyMRI can provide information useful in determining diagnosis. SyMRI is indicated for head imaging. SyMRI can also generate multiple contrast weighted images from the parametric maps generated by post-processing data from M2D-MDME sequence. SyMRI enables post-acquisition image contrasts adjustments from acquisition using M2D-MDME sequence. When M2D-MDME acquisition data is used as input to SyMRI the synthetic contrast weighted images can also provide information useful in determining diagnosis. SyMRI is intended to be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
14
In Commercial Distribution

  • 07340024700061 ()


  • MRI system application software

SyMRI - 07340024700023

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast adjustment. SyMRI is indicated for head imaging. When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).
SyntheticMR AB (publ)
10
In Commercial Distribution

  • 07340024700023 ()


  • MRI system application software

SPINEMAP - 07613327359985

SPINEMAP¿ 3D 3.1 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6002-680-100
In Commercial Distribution

  • 07613327359985 ()
6002-680-100

  • Surgical planning/navigation-enhancement system

SPINEMAP - 07613327359978

SPINEMAP¿ 3D 3.1 - ENABLE
Stryker Leibinger GmbH & Co. KG
6002-680-300
In Commercial Distribution

  • 07613327359978 ()
6002-680-300

  • Surgical planning/navigation-enhancement system

SPINEMAP - 07613327359961

SPINEMAP¿ 3D 3.1 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81039
In Commercial Distribution

  • 07613327359961 ()
81-81039

  • Surgical planning/navigation-enhancement system

SPINEMAP - 07613327359954

SPINEMAP¿ 3D 3.1 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-680-000
In Commercial Distribution

  • 07613327359954 ()
6002-680-000

  • Surgical planning/navigation-enhancement system

SpineMap Go - 07613327413007

SpineMap Go - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81041
In Commercial Distribution

  • 07613327413007 ()
81-81041

  • Surgical planning/navigation-enhancement system
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