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EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images are not intended for diagnostic review.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
EXA 01-04-000
In Commercial Distribution
- 00817100020193 ()
- Diagnostic x-ray digital imaging system workstation
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-06-000
In Commercial Distribution
- 00817100020490 ()
- Diagnostic x-ray digital imaging system workstation
Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-04-000
In Commercial Distribution
- 00817100020209 ()
- Diagnostic x-ray digital imaging system workstation
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-BAA-BXXXX
Not in Commercial Distribution
- 00817655021270 ()
- Patient health record information system
Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-DAACA
Not in Commercial Distribution
- 00817655020617 ()
- Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution
- 00817655022802 ()
- Patient health record information system
The VUZE System (the “System”) enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device guidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7.
The user of the VUZE System is a surgeon with the required qualifications for performing applicable spine surgeries. The System offers pre-operative surgical planning, including implant screw sizing and trajectory determination, as well as intra-operative assistance along the insertion of typical surgical tools (including tools used for placing implants) relative to rigid spinal structures.
VUZE MEDICAL LTD
VM-PK-001
In Commercial Distribution
- 07290019776000 ()
- 07290019776017 ()
VM-PK-001
- Diagnostic x-ray digital imaging system workstation
The FFRangio System is a non invasive image based software device
CATHWORKS LTD
FAU04000
In Commercial Distribution
- 17290017855056 ()
- 07290017855059 ()
FAU04000
- Diagnostic x-ray digital imaging system workstation
The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of a coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The FFRangio™ System performs all required processing and calculations based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure.
CATHWORKS LTD
FAU01000
In Commercial Distribution
- 17290017855025 ()
- 07290017855028 ()
FAU01000
- Diagnostic x-ray digital imaging system workstation
LessRay Monitor & Bracket, 15.6" Touch
Nuvasive, Inc.
8230007
In Commercial Distribution
- 00887517732729 ()
- Diagnostic x-ray digital imaging system workstation