JBD-01K

JLK Inc.

JBD-01K is a software that provides the presence and location of breast tumors and microcalcifications through AI-based analysis of Mammography images obtained from examinee. This product works in conjunction with the PACS (Picture Archiving and Communication System) to access and review data compliant with DICOM (Digital Imaging and Communications in Medicine).

Information source: Vendor
Last updated: July 1, 2020

General Information

General
Product name	JBD-01K
Company	JLK Inc.
Subspeciality	Breast
Modality	Mammography
Disease targeted	Breast cancer, microcalcifications
Key-features	Breast mass detection, micro-calcification detection, report generation
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps), report suggestion

Technical Specifications

Data characteristics
Population	all mammography
Input	2D Mammography DICOM Image
Input format	DICOM, JPG
Output	Location annotation, probability of breast tumor and microcalcification, report (pdf)
Output format	UI, Report
Technology
Integration	Stand-alone third party application, Stand-alone webbased
Deployment	Locally on dedicated hardware, Cloud-based, Hybrid solution
Trigger for analysis	On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	3 - 10 seconds

Regulatory

Certification
CE	Certified, Class I , MDD
FDA	No or not yet
Intended Use Statements
Intended use (according to CE)

Market

Market presence
On market since	01-2020
Distribution channels
Countries present (clinical, non-research use)	1
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Pay-per-use, Subscription
Based on	Number of users, Number of installations

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance
Other relevant papers