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No Description
SCC SOFT COMPUTER
4.5.3.1
In Commercial Distribution
- 00859474006175 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.13
In Commercial Distribution
- 00859474006151 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
4.5.4.0
In Commercial Distribution
- 00859474006137 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.1.3.1
In Commercial Distribution
- 00859474006113 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.3.3
In Commercial Distribution
- 00859474006090 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.12
In Commercial Distribution
- 00859474006083 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.3.2
In Commercial Distribution
- 00859474006069 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
1.0.0.11
In Commercial Distribution
- 00859474006045 ()
- Bedside information system application software
No Description
SCC SOFT COMPUTER
25.5.4.0
In Commercial Distribution
- 00859474006038 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.5.2.1
In Commercial Distribution
- 00859474006021 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.3.1.0
In Commercial Distribution
- 00859474006014 ()
- Blood bank information system application software
No Description
SCC SOFT COMPUTER
25.1.3.0
In Commercial Distribution
- 00859474006007 ()
- Blood bank information system application software
MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightly integrates donor, unit and patient history information with data in the Electronic Health Record (EHR). The software's significant performance characteristics are flagging abnormal test results, reporting test and transfusion results, minimizing product waste, utilizing expert rules when recording and performing error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges.
MEDICAL INFORMATION TECHNOLOGY, INC.
Expanse
In Commercial Distribution
- 00863529000148 ()
- Blood bank information system application software
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Client Server
In Commercial Distribution
- 00863529000117 ()
- Blood bank information system application software
MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times.
MEDICAL INFORMATION TECHNOLOGY, INC.
Magic
In Commercial Distribution
- 00863529000100 ()
- Blood bank information system application software
No Description
VETERANS AFFAIRS, UNITED STATES DEPARTMENT OF
VBECS 2.4.0
In Commercial Distribution
- 00860271000952 ()
- Blood bank information system application software
The bexWISE API (v1.0) is for use in blood establishments to facilitate communication between 510(k) cleared Blood Establishment Computer Systems (BECS), allowing the exchange of donor and donation-related data used to determine donor eligibility and donation suitability.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution
- 00867268000421 ()
- Blood bank information system application software
The LifeTec Elite system is a blood establishment computer system that receives and stores data in the manufacture of blood and blood components, which blood establishments rely on for making decisions regarding the release of blood components for transfusion or further manufacturing. Specifically, laboratory testing, product manufacturing and inventory control/distribution.
IT SYNERGISTICS, LLC
1.0
In Commercial Distribution
- 00867268000414 ()
- Blood bank information system application software
The DoVac Elite system is a web-based application that provides functions for managing donors, donations and the collection process. The system identifies results and responses throughout the process that can be considered ‘high-risk’ to the general blood supply which notifies and allows a staff member to complete a review to determine donor suitability. The DoVac Elite application is capable of capturing all information in the collection process: registration, physical exam, computer assisted medical questionnaire, donor consent, donation identification number assignment, phlebotomy, supervisor review and audit. The system maintains a complete record of all interactions throughout including the donation process, device interfaces, auditing and donor/donation maintenance functions.
IT SYNERGISTICS, LLC
2.0
In Commercial Distribution
- 00867268000407 ()
- Blood bank information system application software
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution
- 00866489000036 ()
740769
- Pipetting system
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
718463
In Commercial Distribution
- 00866489000012 ()
718463
- Electronic pipette
The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
30055067
In Commercial Distribution
- 00866489000005 ()
30055067
- Electronic pipette
No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2018
In Commercial Distribution
- 00853023006173 ()
- Blood bank information system application software
No Description
Cerner Corporation
Bridge2016
In Commercial Distribution
- 00853023006104 ()
- Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion 2012
In Commercial Distribution
- 00853023006098 ()
- Blood bank information system application software
No Description
Cerner Corporation
PathNet Blood Bank Transfusion2015
In Commercial Distribution
- 00853023006067 ()
- Blood bank information 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
No Description
VUNO Inc.
VN-M-30
In Commercial Distribution
- 08800045800342 ()
- X-ray image interpretive software
Designated Medical Device, Critical Care Suite PACS 1.0
GE MEDICAL SYSTEMS, INC.
PACS 1.0
In Commercial Distribution
- 00840682147231 ()
- X-ray image interpretive software
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
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues:
• Documentation of weight changes
• Documentation of energy expenditure and energy reserves
• Documentation of cardiometabolic risk
• Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy
• Documentation of a patient’s fluids status and documentation of changes in fluids
• Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution
- 04012030013406 ()
1151300010
- Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues:
• Documentation of weight changes
• Documentation of energy expenditure and energy reserves
• Documentation of cardiometabolic risk
• Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy
• Documentation of a patient’s fluids status and documentation of changes in fluids
• Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution
- 04012030013383 ()
1151306010
- Medical equipment clinical data interfacing software
The seca 115 PC software is for administering weight, height, bioimpedance and vital measurements and for calculating automatically parameters such as FMI (fat mass index) which can be derived from these measurements. Results are displayed in graphical form and provide support with the following medical issues:
• Documentation of weight changes
• Documentation of energy expenditure and energy reserves
• Documentation of cardiometabolic risk
• Documentation of metabolic activity and the success of a training program, e.g. within the framework of rehabilitation or physiotherapy
• Documentation of a patient’s fluids status and documentation of changes in fluids
• Documentation of changes in vital signs
seca GmbH & Co. KG
115
Not in Commercial Distribution
- 04012030013376 ()
1151303010
- Medical equipment clinical data interfacing software
The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
Moon Surgical Inc
100
In Commercial Distribution
- 03770025849096 ()
- Surgical camera holder
No Description
MILVUE
V2.x.x
In Commercial Distribution
- 03770024774016 ()
- X-ray image interpretive software
No Description
MAK-SYSTEM GROUP LIMITED
v5.0.3
In Commercial Distribution
- 03665324000050 ()
- Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
5.0.1
In Commercial Distribution
- 03665324000036 ()
- Blood bank information system
No Description
MAK-SYSTEM GROUP LIMITED
v2.0
In Commercial Distribution
- 03665324000005 ()
- Blood bank information system
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution
- 00190198909527 ()
- Self-care monitoring/reporting software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution
- 00190198909510 ()
- Self-care monitoring/reporting software
GeTraP is a software application used to support daily operations of product logistics primarily organizing and controlling the information about the transport of plasma units between facilities such as warehouses and fractionators. GeTraP supports trained personnel in tracking data received from suppliers, verifying each plasma units’ suitability for further manufacture.
KEDRION SPA
3.x.x.x
In Commercial Distribution
- 08055271669762 ()
- Blood bank information system application software
StrokeViewer LVO Triaging is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard of care imaging interpretation.
NICo-Lab B.V.
3
In Commercial Distribution
- 08720299502338 ()
- X-ray image interpretive software
Pyxis Transfusion Verification
CAREFUSION 303, INC.
TRANSFUSION
Not in Commercial Distribution
- 10885403421532 ()
- Blood bank information system application software