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No Description
CORTECHS LABS INC
NQ
In Commercial Distribution
- 00863725000300 ()
- MRI system application software
Etiometry Platform
ETIOMETRY INC.
2
In Commercial Distribution
- 00863061000309 ()
- Clinical management support software
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution.
STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.
Spintech, Inc.
2.3
In Commercial Distribution
- 00866463000465 ()
REF 200008
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
Spintech, Inc.
2
Not in Commercial Distribution
- 00866463000441 ()
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
Spintech, Inc.
1.1
Not in Commercial Distribution
- 00866463000410 ()
- MRI system application software
The Decisio Health Patient Dashboard (“Patient Dashboard”) is a data aggregation and visualization software device. The Patient Dashboard is designed to display patient information, facility specific care protocols, and visual cues to care providers on a single display device. The Patient Dashboard is configured to receive patient data through the facility’s Electronic Medical Record system and display information to the user on a patient monitor, computer, or a mobile device. Data received through the EMR includes input from various sources within the hospital, including manually entered data into the EMR (e.g., laboratory data), vital signs monitors, ventilators, IV pumps, and Foley catheter devices. The data the Patient Dashboard receives are then stored, filtered, and displayed through the Patient Dashboard web browser application. The Patient Dashboard is customized to individual facility’s care as it is programmed with the facility’s treatment protocols, which dictate the information that is displayed relative to those protocols. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.
DECISIO HEALTH, INC.
2
In Commercial Distribution
- 00865683000309 ()
- Clinical management support software
The Surgical Light Control and Surgical Camera Control for the Harmony IQ 3600 Integration Systems promotes efficient and prompt reaction to procedure events.
BLACK DIAMOND VIDEO, INC.
Harmony iQ 3600
Not in Commercial Distribution
- 00724995199142 ()
RLQ3600SLC
- Operating room audiovisual data/device management system application software
The Surgical Light Control and Surgical Camera Control for the Harmony IQ 2800 Integration Systems promotes efficient and prompt reaction to procedure events.
BLACK DIAMOND VIDEO, INC.
Harmony iQ 2800
Not in Commercial Distribution
- 00724995199135 ()
RLQ2000SLC
- Operating room audiovisual data/device management system application software
The HexaVue Surgical Camera Control OR Integration software module allows the remote control of surgical camera.
BLACK DIAMOND VIDEO, INC.
HexaVue SCC 1.0
In Commercial Distribution
- 00724995198503 ()
XQHILCC1
- Operating room audiovisual data/device management system application software
The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals.
BLACK DIAMOND VIDEO, INC.
HexaVue-SLC 1.0
In Commercial Distribution
- 00724995198497 ()
XQHLC1
- Operating room audiovisual data/device management system application software
The IDSS Integration System with Surgical Camera Control is an integrated audio-visual system which combines monitors, medical imaging devices, lights, music, and cameras.
BLACK DIAMOND VIDEO, INC.
IDSS-SCC
Not in Commercial Distribution
- 00724995198473 ()
XQSILCC1
- Operating room audiovisual data/device management system application software
ORTHO CONNECT™ Software is designed to collect data from the Ortho Clinical Diagnostics blood typing instruments and its proprietary immunohematology reagent system, which allows operators to track individual patient and donor samples and link them to the appropriate test results. The software collates the results from testing, assigns outcomes to individual samples according to configured rules, and formats output files that can be sent to a Laboratory Information Management System (LIMS).
ORTHO CONNECT™ Software is intended to be used by Blood Establishments and by personnel who are trained in its operation.
BIOMEDICAL DATA SOLUTIONS LIMITED
3.0
In Commercial Distribution
- 05060496770066 ()
- Laboratory instrument/analyser application software IVD
FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo.
The software application is a measuring medical device intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients.
The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management.
FerriSmart is indicated to:
• measure liver iron concentration in individuals with confirmed or suspected systemic iron overload
• monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions
• aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v01
In Commercial Distribution
- 09369998038619 ()
- MRI system application software
No Description
ECHOIQ LIMITED
1.5.0
In Commercial Distribution
- 09309001128005 ()
- Cardiovascular interpretive screening software
Kosmos Application loaded on an iPad.
ECHONOUS, INC.
iOS 4.X
Not in Commercial Distribution
- 09353278000823 ()
- Ultrasound imaging system application software
The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to
experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Fifth Eye, Inc.
2
In Commercial Distribution
- B823AHIV200 ()
- Clinical management support software
Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
Fifth Eye, Inc.
P1
In Commercial Distribution
- B823AHIP100 ()
- Clinical management support software
Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
DIAGNOLY
1
In Commercial Distribution
- 03770033463000 ()
- Ultrasound imaging system application software
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
BRIGHTHEART
V1.0.0
In Commercial Distribution
- 03760415600000 ()
- Ultrasound imaging system application software
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol.
Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following:
Automatically detect views;
Automatically detect anatomical structures within the supported views;
Automatically verify quality criteria of the supported views by checking whether they conform to standardized quality criteria
SONIO
2
In Commercial Distribution
- 03770024341041 ()
- Ultrasound imaging system application software
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN
MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following)
to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by
Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and
Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in
assuring during and after their examination that the examination is complete and all images were
collected according to their protocol.
SONIO
1
In Commercial Distribution
- 03770024341027 ()
- Ultrasound imaging system application software
iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution
- 10837461002475 ()
800-3704
- Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution
- 03607450000030 ()
87111
- 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
BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution
- 03610520519813 ()
- 1 Each
6653475A
- Laboratory instrument/analyser application software IVD
U.S. IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, SW 4.3_v5
BIO-RAD LABORATORIES, INC.
SW4.3_v5
In Commercial Distribution
- 03610520178904 ()
- 1 Each
12003844
- Laboratory instrument/analyser application software IVD
OAS Server for VERSEIA Integrated Processor (VIP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842840
In Commercial Distribution
- 10758750012763 ()
6842840
- 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
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
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0250-0101-7
In Commercial Distribution
- 04049016135210 ()
- Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0011-0101
In Commercial Distribution
- 04049016068815 ()
- Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0006-0101
In Commercial Distribution
- 04049016068785 ()
- Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0071-0101
In Commercial Distribution
- 04049016148708 ()
- Laboratory instrument/analyser application software IVD
No Description
Quantib B.V.
2.2
In Commercial Distribution
- 08719689791261 ()
- MRI system application software
No Description
Quantib B.V.
1.5
In Commercial Distribution
- 08719689791254 ()
- MRI system application software
No Description
Quantib B.V.
2.1
In Commercial Distribution
- 08719689791216 ()
- MRI system application software
No Description
Quantib B.V.
2.0
In Commercial Distribution
- 08719689791179 ()
- MRI system application software