cmTriage

GUDID 00860006442668

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.

Radiology DICOM image processing application software

• Primary Device ID: 00860006442668
• NIH Device Record Key: 254750c0-535d-452b-86be-3610813a1643
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cmTriage
• Version Model Number: V1.0
• Company DUNS: 080081187
• Company Name: Curemetrix, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006442668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183285

FDA Product Code

• QFM: Radiological Computer-Assisted Prioritization Software For Lesions

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-08
• Device Publish Date: 2023-10-31

Devices Manufactured by Curemetrix, Inc.

• 00860006442668 - cmTriage: 2023-11-08cmTriage 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.
• 00860006442668 - cmTriage: 2023-11-08 cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize s
• 00860006442682 - cmAngio: 2023-11-08 cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of i