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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
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 and should not be used alone to make any diagnosis and/or treatment decisions.
cmAngio is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution
- 00860006442682 ()
- Radiology DICOM image processing application software
cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. These flags are viewed by the radiologist via their Picture Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use cmTriage codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist.
Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care.
cmTriage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the radiologist’s worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis.
cmTriage is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution
- 00860006442668 ()
- Radiology DICOM image processing application software
No Description
Tasso Inc.
K1015-01
Not in Commercial Distribution
- 00860006434595 ()
- Manual blood lancing device, single-use
Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.
Tasso Inc.
K1016-02
Not in Commercial Distribution
- 00860006434588 ()
- Capillary blood collection system IVD
Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.
Tasso Inc.
K1016-01
Not in Commercial Distribution
- 00860006434571 ()
- Capillary blood collection system IVD
Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.
Tasso Inc.
K1016-03
Not in Commercial Distribution
- 00860006434564 ()
- Capillary blood collection system IVD
Tasso+ convenience kit allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.
Tasso Inc.
K1016-04
Not in Commercial Distribution
- 00860006434557 ()
- Capillary blood collection system IVD
The Tasso-M20 is used to collect, store, and transport capillary blood for testing in a centralized laboratory. It is to be used in non-clinical settings for use in adult populations.
Tasso Inc.
K1001-02
In Commercial Distribution
- 00860006434540 ()
- Capillary blood collection system IVD
Tasso+ allows self-collection of a capillary blood sample that is shipped to an accredited laboratory for analysis.
Tasso Inc.
K1011-04
Not in Commercial Distribution
- 00860006434533 ()
- Capillary blood collection system IVD