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No Description
Siemens Healthcare GmbH
11546320
In Commercial Distribution
- 04056869267456 ()
- CT system application software
Pyxis Transfusion Verification
CAREFUSION 303, INC.
TRANSFUSION
Not in Commercial Distribution
- 10885403421532 ()
- Blood bank information system application software
No Description
Heuron Co., Ltd.
ST-ICT01
In Commercial Distribution
- 08800086200217 ()
- Radiology DICOM image processing application software
Lunit INSIGHT CXR Triage - Windows version
Lunit Inc.
1.0
In Commercial Distribution
- 08800076000179 ()
- X-ray image interpretive software
Linux version
Lunit Inc.
1.0
In Commercial Distribution
- 08800076000124 ()
- X-ray image interpretive software
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager includes the following features:
• Bidirectional connectivity with one or more LIS.
• Provides the ability to centralize the management of Quality Control.
• Allows user to view and validate results remotely prior to export to LIS.
• Allows to create and print reports.
Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
In Commercial Distribution
- 08436583731215 ()
210404
- Blood bank information system application software
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and
managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
Not in Commercial Distribution
- 08436583730980 ()
210404
- Blood bank information system application software
IH-AbID Integrated Antibody Identification Software is an optional software module for IHCom that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. The IH-AbID module graphically displays the ruling out of antibodies to red blood cell antigens by reproducing the same logic techniques of antibody identification used in blood transfusion laboratories. For use by trained laboratory personnel, in a (blood transfusion) laboratory environment.
Bio-Rad Medical Diagnostics GmbH
12010902
In Commercial Distribution
- 03610522136421 ()
12010902
- Laboratory instrument/analyser application software IVD
CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen.
The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings.
CINA-VCF uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device.
This document is the property of Avicenna.AI and cannot be reproduced without written authorisation.
The results of CINA-VCF are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINAVCF100 ()
- Radiology DICOM image processing application software
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with
detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA-iPE are intended to be used in conjunction with other patient information and based on professional judgment to assist with the triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINAIPE100 ()
- Radiology DICOM image processing application software
CINA-CSpine is a radiological computer-assisted triage and notification software device. CINA-CSpine runs on a standard “off the shelf” server/workstation and consists of CSpine Image Processing Application, which can be integrated, deployed and used with the CINA Platform or other medical image communications devices. CINA-CSpine receives cervical spine CT scans identified by the CINA Platform or other medical image communications device, processes them using algorithmic methods involving execution of multiple computational steps to identify the suspected positive findings compatible with acute cervical spine fractures and generates results files to be transferred by CINA Platform or a similar medical image communications device for output to a PACS system or workstation for worklist prioritization.
To identify the suspected presence of cervical fractures, the device uses a deep learning model trained end-to-end on 1,338 cases acquired from US and France, representing a distribution of fracture presentations, locations and acquisition protocols, including multiple scanner models. Additional deep learning models are used to locate the individual vertebrae to exclude images that do not conform to the expected field of view.DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of a cervical spine fracture, then active notifications on the flagged series are sent to the worklist application. The Worklist Application displays the active notification of new studies with suspected findings when they come in. All the cervical spine CT studies which include at least 5 visible cervical vertebrae received by CINA-CSpine device are displayed in the worklist and those on which the algorithms have detected a suspected finding are marked with an icon [...].
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINACSPINE100 ()
- Radiology DICOM image processing application software
CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiographies. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiographies for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiographies for Aortic Dissection (AD). CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD on a standalone Web application in parallel to the ongoing standard of care image interpretation.
The user is presented with notifications for cases with suspected PE or AD findings. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA CHEST are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINACHEST100 ()
- Radiology DICOM image processing application software
CINA is a radiological computer-assisted triage and notification software device.
The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications.
DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application.
The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active
notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiographies studies received by CINA device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked “not for diagnostic use” is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
AVICENNA.AI
1.0
In Commercial Distribution
- B826CINA100 ()
- Radiology DICOM image processing application software
No Description
Medit Corp.
2.0
In Commercial Distribution
- 08800026700869 ()
- CAD/CAM software
StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution
- B926SSSX10 ()
- CT system application software
Vital Sync Weaning Readiness and Spontaneous Breathing Trial Monitoring Application v1 Software with OUS Support
Covidien LP
WRSBTSW01
In Commercial Distribution
- 10884521762633 ()
- Multiparameter physiologic analysis workstation
Vital Sync Early Warning Score Application v1 Software with OUS Support
Covidien LP
EWSSW01
In Commercial Distribution
- 10884521762626 ()
- Multiparameter physiologic analysis workstation
Critical Care Suite 2.0, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.0
In Commercial Distribution
- 00195278217981 ()
- X-ray image interpretive software
ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS).
ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution
- 10888234002475 ()
- Laboratory instrument/analyser application software IVD
UIMS Viewing Station SC High Line
Dornier MedTech GmbH
UIMS
In Commercial Distribution
- 04049957000578 ()
K1029226
- Basic diagnostic x-ray system operation software
UIMS Viewing Station SC Low Line
Dornier MedTech GmbH
UIMS
In Commercial Distribution
- 04049957000561 ()
K1029225
- Basic diagnostic x-ray system operation software
UIMS Viewing Station
Dornier MedTech GmbH
UIMS
In Commercial Distribution
- 04049957000554 ()
K1028986
- Basic diagnostic x-ray system operation software
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution
- 00850003095011 ()
- Diagnostic x-ray digital imaging system workstation
- X-ray image interpretive software
Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution
- 05020583252035 ()
- Blood bank information system
Information System Version 4, Vista Standard Interface and SafeTrace®
BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution
- 05020583252028 ()
- Blood bank information system
Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution
- 05020583252011 ()
- Blood bank information system
TOMEs Terumo Operational Medical Equipment Software Version 7.3
TERUMO BCT, INC.
11401
In Commercial Distribution
- 05020583114012 ()
11401
- Blood bank information system application software
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
BioWink GmbH
1
In Commercial Distribution
- 04260749840008 ()
- Self-care monitoring/reporting software
autoclavable accessories for the DEXTER ENDOSCOPE ARM
Aktormed GmbH
212518
In Commercial Distribution
- 04260463845181 ()
212518
- Surgical camera holder
autoclavable accessories for the DEXTER ENDOSCOPE ARM
Aktormed GmbH
212482
In Commercial Distribution
- 04260463844825 ()
212482
- Surgical camera holder