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No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431553
In Commercial Distribution
- 04056869279800 ()
- SPECT system application software
- PET system application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11545289
In Commercial Distribution
- 04056869274638 ()
- Radiology DICOM image processing application software
AI-Rad Companion Prostate MR About Box
Siemens Healthcare GmbH
11294432
Not in Commercial Distribution
- 04056869257952 ()
- Radiology DICOM image processing application software
No Description
Samsung Electronics Co., Ltd.
1.1
In Commercial Distribution
- 08806090792021 ()
- Electrocardiographic monitor
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution
- 04547410541199 ()
- Endoscopic video image interpretive software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution
- 04068151027013 ()
- PET system application software
- SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution
- 04068151009477 ()
- PET system application software
- SPECT system application software
No Description
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution
- 05060634690027 ()
- Radiology DICOM image processing application software
- Cardiac mapping system application software
- Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Core
In Commercial Distribution
- 05060634690003 ()
- Radiology DICOM image processing application software
- Cardiac mapping system application software
- Ultrasound imaging system application software
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
Curemetrix, Inc.
V1.6
In Commercial Distribution
- 00860006442699 ()
- Radiology DICOM image processing application software