# K183285: cmTriage

- Pathway: 510(k) (Traditional)
- Applicant: Curemetrix, Inc.
- Decided: Mar 8, 2019 after 102 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170073 (2018). 1 ancestor in all.
37 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170073: ContaCT, Viz.Al, Inc. (2018) Summary page 4.

## Most influential descendants
- K190362: HealthPNX (2019), 23 descendants of its own
- K192320: HealthCXR (2019), 9 descendants of its own
- K183182: Critical Care Suite (2019), 8 descendants of its own
- K211733: Lunit INSIGHT CXR Triage (2021), 7 descendants of its own
- K192901: HealthVCF (2020), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K183285
Methodology: https://510kreport.com/methodology