Radiology · 510(k) · 2019
cmTriage
CureMetrix, Inc. Cleared by FDA on 8 March 2019 under submission K183285, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K183285
- Device. cmTriageDEVICE
- Company. CureMetrix, IncCOMPANY
- Decision. 8 March 2019, 510(k), substantially equivalent (traditional review); received 26 November 2018DECISION
- Panel. RadiologyPANEL
- Product code. QFM, Radiological Computer-Assisted Prioritization Software For LesionsCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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. Technological Characteristics cmTriage is a software only device that can be segmented into three components: (1) Image Forwarding and Result File Receiving Software, (2) Image Processing and Analysis Software, and (3) Notification Result File. The Image Forwarding and Result File Receiving Software is configured by the hospital to interact with […]
The product code's definition, from FDA's classification record. Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QFM. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QFM, in Radiology, from CureMetrix, Inc, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.