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ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-01-00-000
In Commercial Distribution
- 00817100020407 ()
- Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution
- 00817100020186 ()
- Diagnostic x-ray digital imaging system workstation application software
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-02-01-000
In Commercial Distribution
- 00817100020179 ()
- Diagnostic x-ray digital imaging system workstation application software
Software for analysis of echocardiogram
EPSILON IMAGING
3.2.0
Not in Commercial Distribution
- B557ECHOINSIGHT0 ()
- Cardiac mapping 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
KNEE ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOP73KNKLA
In Commercial Distribution
- 50197106842872 ()
- 10197106842874 ()
SOP73KNKLA
- Decontamination floor mat, single-use
TOTAL JOINT PACK
Cardinal Health 200, LLC
SOPDHTJWK4
In Commercial Distribution
- 50197106831630 ()
- 10197106831632 ()
SOPDHTJWK4
- Decontamination floor mat, single-use
ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOP73APBS1
In Commercial Distribution
- 50197106827497 ()
- 10197106827499 ()
SOP73APBS1
- Decontamination floor mat, single-use
The iQMR is a software package, connected to the clinic LAN, that receive and transfer MRI images.
The image processing provide enhanced quality by reducing the image noise level.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.2
In Commercial Distribution
- 07290016836400 ()
- MRI system application software
KNEE ARTHROSCOPY PACK
Cardinal Health 200, LLC
SOP23KAMAA
In Commercial Distribution
- 50197106768691 ()
- 10197106768693 ()
SOP23KAMAA
- Decontamination floor mat, single-use