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No Description
Siemens Healthcare GmbH
11546418
In Commercial Distribution
- 04056869287393 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546417
In Commercial Distribution
- 04056869287386 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546336
In Commercial Distribution
- 04056869267463 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546318
In Commercial Distribution
- 04056869267425 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546307
In Commercial Distribution
- 04056869267340 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11546136
In Commercial Distribution
- 04056869252230 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11270038
In Commercial Distribution
- 04056869251233 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11270037
In Commercial Distribution
- 04056869251226 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11270036
In Commercial Distribution
- 04056869251219 ()
- CT system application software
No Description
Siemens Healthcare GmbH
11270035
In Commercial Distribution
- 04056869251202 ()
- CT system application software
syngo.Interventional VB40; Medical Device syngo.Interventional VB40 is covered by NFJ to K190780 syngo Application Software VE20
Siemens Healthcare GmbH
11327988
In Commercial Distribution
- 04056869248653 ()
- Basic diagnostic x-ray system application software
syngo.Interventional VB30; Medical Device syngo.Interventional VB30 is covered by NFJ to K170747 syngo Application Software VD20
Siemens Healthcare GmbH
11327747
In Commercial Distribution
- 04056869164311 ()
- Basic diagnostic x-ray system application software
syngo.Interventional VB20; Medical Device syngo.Interventional VB20 is covered by NFJ to K143319 Syngo X-Workplace VD10
Siemens Healthcare GmbH
10849169
In Commercial Distribution
- 04056869026305 ()
- Basic diagnostic x-ray system application software
syngo.Interventional VB10;Medical Device syngo.Interventional VB10 is covered by NFJ to K143319 "Syngo X-Workplace SW VD10"
Siemens Healthcare GmbH
10849138
In Commercial Distribution
- 04056869020518 ()
- Basic diagnostic x-ray system application software
syngo.Interventional VA30;Medical Device syngo.Interventional VA30 is covered by NFJ to K042995 X-LEONARDO;
Siemens Healthcare GmbH
10849137
In Commercial Distribution
- 04056869020501 ()
- Basic diagnostic x-ray system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10183757
In Commercial Distribution
- 04056869002477 ()
- PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10119386
In Commercial Distribution
- 04056869002385 ()
- PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10764036
In Commercial Distribution
- 04056869002088 ()
- PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10276007
In Commercial Distribution
- 04056869002071 ()
- PET system application software
No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution
- B745VASCUCAPA2 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution
- B745ELUCIDVIVOA3 ()
- CT system application software
No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution
- B745A40 ()
- CT system application software
VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution
- E247E7300A10 ()
- General-purpose dental x-ray system application software
No Description
DÜRR DENTAL SE
E7200
Not in Commercial Distribution
- E247E72000 ()
- General-purpose dental x-ray system application software
Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.3
In Commercial Distribution
- B816VNC2P30 ()
N/A
- CT system application software
Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.1.0
In Commercial Distribution
- B816VNC2P10 ()
N/A
- CT system application software
No Description
EOS IMAGING
1.10
In Commercial Distribution
- 03663999000153 ()
- Basic diagnostic x-ray system application software
sterEOS workstation
EOS IMAGING
Workstation 1.8
In Commercial Distribution
- 03663999000047 ()
- Basic diagnostic x-ray system application software
sterEOS workstation
EOS IMAGING
Workstation 1.6
In Commercial Distribution
- 03663999000023 ()
- Basic diagnostic x-ray system application software
Will3D is one of the components of a Picture Archiving and Communications System(PACS). Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
HDX WILL CORP.
Will3D
In Commercial Distribution
- 08800005200298 ()
- General-purpose dental x-ray system application software
WillCeph is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images, including digitla photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions
HDX WILL CORP.
WillCeph
In Commercial Distribution
- 08800005200168 ()
- General-purpose dental x-ray system application software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936889 ()
- Patient general health self-management software
The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.
This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.
This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution
- 08806094936872 ()
- Patient general health self-management software
Ablation Planning Application
Covidien LP
CAMPA
Not in Commercial Distribution
- 10884521214026 ()
- CT system application software
VATS Planning Application
Covidien LP
CAMPV
Not in Commercial Distribution
- 10884521214019 ()
- CT system application software
Procedure Planning Application
Covidien LP
CAMPP
Not in Commercial Distribution
- 10884521214002 ()
- CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution
- 00840682146586 ()
- CT system application software
No Description
GE MEDICAL SYSTEMS, INC.
2
In Commercial Distribution
- 00840682142601 ()
- CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution
- 00840682134989 ()
- CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution
- 00840682134972 ()
- CT system application software
No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2008
In Commercial Distribution
- 10856602005144 ()
- Medication adherence telemetric monitoring system, post-ingestion
EVA SELECT SIZE 2 SENSOR
ImageWorks
9992412205
In Commercial Distribution
- D83399924122050 ()
9992412205
- General-purpose dental x-ray system application software
EVA SELECT SIZE 1 SENSOR
ImageWorks
9992412105
In Commercial Distribution
- D83399924121050 ()
9992412105
- General-purpose dental x-ray system application software
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SYS-1500
Not in Commercial Distribution
- 00815686020057 ()
SYS-1500
- Virtual bronchoscopic navigation PACS software
TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
medimaps group SA
4.0
In Commercial Distribution
- B214OSTBSIV400 ()
- Basic diagnostic x-ray system application software
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (iOS)
Tandem Diabetes Care, Inc.
1007111
In Commercial Distribution
- 90850018992452 ()
- Ambulatory insulin infusion pump software, data-display
- Ambulatory insulin infusion pump remote control
t:connect Mobile Application, Mobile Bolus Enabled, 2.x (Android)
Tandem Diabetes Care, Inc.
1007112
In Commercial Distribution
- 90850018992445 ()
- Ambulatory insulin infusion pump software, data-display
- Ambulatory insulin infusion pump remote control
LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution
- 60889971029881 ()
1029883
- Basic diagnostic x-ray system application software
LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM DENTAL LLC
Logicon Caries Detector
Not in Commercial Distribution
- 60192156851628 ()
8008690
- General-purpose dental x-ray system application software
CS IMAGING CLIENT SERVER SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
Not in Commercial Distribution
- 60192155943010 ()
5943014
- General-purpose dental x-ray system application software