cmTriage

Primary DI
00860006442668
Brand
cmTriage
Company
Curemetrix, Inc.
Model
V1.0
Device description
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.
Published
2023-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183285000cmTriageCuremetrix, Inc.2019-03-08QFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006442668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006442668008600064426688600064426680860006442668

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/ disc burning) and/or image manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080081187
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006442699cmAngioV1.62025-05-02
00860006442682cmAngioV1.02023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
07290018052365BriefCase TriageAIDOC MEDICAL LTDQFM2026-02-15
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQFM2025-07-28
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-02
M722X25122P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XC25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XD25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
B761R60Rapid Ischemaview, Inc.QFM2025-05-07
03770024774016SmartChestMILVUEQFM2025-03-31
M722X25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
M722XC25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
M722XD25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
07290018052273BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
07290018052297BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
08800045800342VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVUNO Inc.QFM2024-11-19
B826CINAVCF100CINA-VCFAVICENNA.AIQFM2024-06-20
M722XD24079P212210ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2024-04-15
08800076000179Lunit INSIGHT CXR TriageLunit Inc.QFM2024-04-09
B761R51020RapidIschemaview, Inc.QFM2024-02-13
B761R610RapidIschemaview, Inc.QFM2024-02-13
G140ANNALISEENTP50Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2024-01-11
07290018052259BriefCase TriageAIDOC MEDICAL LTDQFM2023-12-27
G140ANNALISEENTP40Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2023-11-06
00850057636017qXR-PTX-PEQURE.AI TECHNOLOGIES PRIVATE LIMITEDQFM2023-10-10
00860007434709Cognet AIMedcognetics IncQFM2023-09-11
G140ANNALISEENTP30Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-07-24
07290018052211BriefCase TriageAIDOC MEDICAL LTDQFM2023-07-14
G140ANNALISEENTP20Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-06-08
00811852030325Viz AAAVIZ.AI, INC.QFM2023-05-22