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The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.
The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.
VentriPoint Diagnostics Ltd
4.0
In Commercial Distribution
- 07540263000049 ()
- Radiology picture archiving and communication system workstation
Ibex Prostate Detect is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intended to identify cases initially diagnosed as benign for further review by a pathologist. If Ibex Prostate Detect detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it provides case- and slide-level alerts (flags) which includes a heatmap of tissue areas in the WSI that is likely to contain cancer.
Ibex Prostate Detect is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized using the Ibex Prostate Detect user interface.
Ibex Prostate Detect outputs are not intended to be used on a standalone basis for diagnosis, to rule out prostatic AdC or to preclude pathological assessment of WSIs according to the standard of care.
IBEX MEDICAL ANALYTICS LTD
3.1-US
In Commercial Distribution
- 07290019124016 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
TruSPECT Radiological Image Processing Station
SPECTRUM DYNAMICS MEDICAL, INC
STANDALONE PROCESSING STATION
In Commercial Distribution
- 07290108670233 ()
8010290-01
- SPECT system workstation
The Evoya Software Platform is an in vitro diagnostics modular software intended to be used together with Neonatal screening assay systems to enable workflow activities, data management, results analysis and reporting. The EVOYA Software Platform is intended to be used by trained laboratory professionals.
The Evoya Software Platform is intended for in vitro diagnostic use.
Wallac Oy
5021-1000
In Commercial Distribution
- 06438147366804 ()
5021-1000
- Clinical laboratory information system
HS6 SERVER RX KIT DICOM PDF XML
WELCH ALLYN, INC.
901143
In Commercial Distribution
- 00732094350753 ()
HSERV-6BA-XXXXB
- Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution
- 00732094345643 ()
HSCRIBE-6AC-DXXXE
- Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution
- 00732094338812 ()
HSCRIBE-6AC-CXXXC
- Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US power cord; HP LaserJet 110V printer; Rx Report Export (UNIPRO and waveform XML) + XML Orders
WELCH ALLYN, INC.
901143
Not in Commercial Distribution
- 00732094327496 ()
HSCRIBE-6AA-AAXXD
- Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution
- 00732094325607 ()
HSCRIBE-6AD-ZXXXE
- Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Rx Report Export (UNIPRO and waveform XML) + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution
- 00732094325591 ()
HSCRIBE-6AC-BXXXE
- Electrocardiographic long-term ambulatory recording analyser application software