cmAngio® (V1.6)
Curemetrix, Inc.
CUREMETRIX, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017173128 | 3017173128 | CUREMETRIX, INC. | 1 | N | 2026-01-01 | 402 West Broadway Suite 400 San Diego CA US 92101 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 275557 | 1629387210 | K250754 | cmAngio® (V1.6) | QIH | 2025-04-10 |
| 275557 | 1220316070 | K232367 | cmAngio® V1.0 | QIH | 2023-10-05 |
| 275557 | 1073603795 | K183285 | cmTriage | QFM | 2019-03-08 |
Product Codes Associated With Registrations#
PMN#
GUDID#
cmAngio - 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.
2025-05-02
cmTriage - 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.
2023-10-31
cmAngio - 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.
2023-10-31