MEDCOGNETICS, INC

FDA Device Registration & Listing · Dallas, TX, US · Registration 3024844299

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024844299
FEI Number
3024844299
Entity Name
MEDCOGNETICS, INC
City/State/Country
Dallas, TX, US
Establishment Address
17217 Waterview Parkway, Suite 1.202E, Dallas, TX 75252, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MedCognetics, Inc (Owner Number: 10086402)
Owner / Operator Contact Address
17217 Waterview Parkway, Suite 1.202E, Dallas, TX 75252, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220080
PMA Number
N/A

All Registered Proprietary Names

CogNet AI-MT+ QmTRIAGE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology Class 2 892.2080 2025-12-16
QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology Class 2 892.2080 2022-11-07

Official Correspondent

John Jenkins

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedCognetics, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190362 Zebra Medical Vision, Ltd. HealthPNX 2019-05-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024844299. Last updated year: 2026. Please use registration number 3024844299 when referencing this establishment in official correspondence.
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