FDA.report

510(k) K252482

Device
CogNet AI-MT+
Applicant
Medcognetics, Inc.
510(k) number
K252482
Product code
QFM
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-11
Date received
2025-08-07
Regulation
892.2080
Classification name
Radiological Computer-Assisted Prioritization Software For Lesions
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
John Jenkins
Address
17217 Waterview Pkwy. Suite 1.202e Dallas TX US 75252 75252

FDA Registration Numbers

Source Documents

510(k) summary PDF

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