IMAGEN TECHNOLOGIES, INC.

FDA Device Registration & Listing · New York, NY, US · Registration 3014661828

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
3014661828
FEI Number
3014661828
Entity Name
IMAGEN TECHNOLOGIES, INC.
City/State/Country
New York, NY, US
Establishment Address
420 Lexington Avenue, Suite 300, Office 365, New York, NY 10170, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Imagen Technologies, Inc. (Owner Number: 10057966)
Owner / Operator Contact Address
224 W 35th Street, Suite 500, New York, NY 10001, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223811
PMA Number
N/A

All Registered Proprietary Names

FX FractureDetect Chest-CAD ChestSuite Aorta-CAD ChestSuite Lung-CAD ChestSuite Lung-CAD

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture Radiology Class 2 892.2090 2020-09-03
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2021-07-21
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2023-04-05
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2024-12-05
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2024-12-05

Official Correspondent

Sarah Gourgoulianis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014661828. Last updated year: 2026. Please use registration number 3014661828 when referencing this establishment in official correspondence.
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