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No Description
GE Vingmed Ultrasound AS
Plug-in v202
In Commercial Distribution
- 00840682123518 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v202
In Commercial Distribution
- 00840682123501 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v113
In Commercial Distribution
- 00840682121095 ()
- Ultrasound imaging system application software
Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution
- 00840682147101 ()
- Ultrasound imaging system application software
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution
- 00840682147071 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v204
In Commercial Distribution
- 00840682146883 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v204
In Commercial Distribution
- 00840682146876 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v203
In Commercial Distribution
- 00840682141703 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v203
In Commercial Distribution
- 00840682141697 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v201
In Commercial Distribution
- 00840682104333 ()
- Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v201
In Commercial Distribution
- 00840682103961 ()
- Ultrasound imaging system application software
The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution
- 08058056685445 ()
06U86-1A
- Laboratory instrument/analyser application software IVD
The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution
- 08058056685438 ()
6U82-1A
- Laboratory instrument/analyser application software IVD
Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution
- B725INITVV1 ()
- B725INITVV12 ()
INITVV
- Ultrasound imaging system application software
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
OAS Server for VERSEIA Integrated Processor (VIP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842840
In Commercial Distribution
- 10758750012763 ()
6842840
- Laboratory instrument/analyser application software IVD
OAS 400 MHz Workstation Refurbished for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936415F
In Commercial Distribution
- 10758750005482 ()
936415F
- Laboratory instrument/analyser application software IVD
OAS Server - 450 MHz, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416F
In Commercial Distribution
- 10758750005505 ()
936416F
- Laboratory instrument/analyser application software IVD
OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution
- 10758750005499 ()
936416
- Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution
- 03607450871111 ()
87111
- Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution
- 03607450867657 ()
86765
- Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution
- 03607450000047 ()
86765
- Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution
- 03607450000030 ()
87111
- Laboratory instrument/analyser application software IVD
Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Opgen, Inc.
CP3511
Not in Commercial Distribution
- 01812125010081 ()
CP3511
- Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine ANCA Classifier
In Commercial Distribution
- 08059304340239 ()
- Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine DNA Classifier
In Commercial Distribution
- 08059304340222 ()
- Laboratory instrument/analyser application software IVD
No Description
VISIA LAB SRL
dIFine ANA HEp-2 Classifier
In Commercial Distribution
- 08059304340215 ()
- Laboratory instrument/analyser application software IVD
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution
- 10385083000565 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution
- 20385083000531 ()
- 10385083000527 ()
- 20385083000579 ()
- 20385083000753 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Starter Kit mg/dl
Insulet Corporation
SKT-M001-G-X9
In Commercial Distribution
- 10385083000503 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution
- 10385083000336 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-BLE-H1-520
In Commercial Distribution
- 10385083000213 ()
- 10385083000114 ()
- 10385083000138 ()
- 20385083000210 ()
- 20385083000135 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Controller (PDM) mg/dl - English with PodPals
Insulet Corporation
PDM-H001-G-XX
In Commercial Distribution
- 10385083000022 ()
- 30385083000019 ()
- 30385083000095 ()
SKT-H001-G-X9
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Actual downloadable APP, called Omnipod 5 Controller APP
Insulet Corporation
1.0
In Commercial Distribution
- 10385081120302 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.
CliniSys, Inc
6.3
Not in Commercial Distribution
- B236SMG6300 ()
- Human genomic analysis interpretive software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.75.20171019
In Commercial Distribution
- B133NEUROQ1 ()
- Neurosurgical ultrasound navigation system application software
NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.6.20131127
In Commercial Distribution
- B133NEUROQ0 ()
- Neurosurgical ultrasound navigation system application software
No Description
Roche Molecular Systems, Inc.
08403864001
Not in Commercial Distribution
- 07613336156551 ()
08403864001
- Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08403856001
In Commercial Distribution
- 07613336156544 ()
08403856001
- Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08302375001
Not in Commercial Distribution
- 07613336150047 ()
08302375001
- Laboratory instrument/analyser application software IVD