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The Cydar EV software produces automated 3D overlays for use in endovascular surgery. The software detects vertebral anatomical information present in live X-ray images and matches ('registers') it to an existing CT scan of the patient in order to determine their precise position. This match then allows a 3D overlay to be generated in the correct position and projection. The Cydar EV software is hosted on cloud high-performance computers in order to accelerate performance
Cydar EV works with both flat panel detectors and image intensifiers on fixed and mobile X-ray sets. The Cydar EV Instructions for Use remain the same for all types of X-ray set.
Note: Federal law (US) restricts this device to sale by or on the order of a physician.
CYDAR LIMITED
EV-2
In Commercial Distribution
- 05060508110002 ()
- Angiographic x-ray system application software
X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled Software License
ST. JUDE MEDICAL, INC.
ENSITE-HDGX-01
In Commercial Distribution
- 05415067051103 ()
ENSITE-HDGX-01
- Cardiac mapping system application software
Sharesourece is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System.
BAXTER INTERNATIONAL INC.
5C9400
Not in Commercial Distribution
- 05413765565694 ()
5C9400
- Nephrology information system application software
Kit
ST. JUDE MEDICAL, INC.
Derexi™
In Commercial Distribution
- 05415067005861 ()
H700586
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution
- 05415067002952 ()
H700295
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution
- 05415067002938 ()
H700293
- Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution
- 05415067002921 ()
H700292
- Cardiac mapping system application software
No Description
Affymetrix, Inc.
1.2
In Commercial Distribution
- 00856826006067 ()
610466
- Laboratory instrument application software IVD
No Description
Affymetrix, Inc.
2.1
In Commercial Distribution
- 00856826006050 ()
610533
- Laboratory instrument application software IVD
Oasis is a SaMD (Software as a Medical Device). It is a software product designed to operate on an office PC. The product is intended for use by qualified medical personnel for the assessment of diagnostic medical images. The Oasis product is not intended to be used as a replacement for visual interpretation, nor as a diagnostic tool without the use of other clinical and laboratory information. The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of automatic and manual processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis is a software-only medical device (a SaMD). Oasis does not directly or indirectly control any medical device that has contact with the user or patient. Oasis does not automate the diagnosis of a patient in any way. Oasis does not come into contact with patients and does not contain medicinal substances or non-viable animal/human tissues.
SEGAMI CORPORATION
V3
- Gamma camera system application software