Therapixel Inc.

FDA Device Registration & Listing · Chicago, IL, US · Registration 3016759115

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
3016759115
FEI Number
3016759115
Entity Name
Therapixel Inc.
City/State/Country
Chicago, IL, US
Establishment Address
1700 W Irving Park Rd ST. 209A, Chicago, IL 60613, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
THERAPIXEL (Owner Number: 10071453)
Owner / Operator Contact Address
1 Impasse Reille, Paris, FR-75 75014, FR
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K243685
PMA Number
N/A

All Registered Proprietary Names

MammoScreen MammoScreen® MammoScreen® 4 Genius AI® Detection PRO MammoScreen MammoScreen 4 Genius AI Detection PRO Density MammoScreen BD Genius AI Detection PRO Density MammoScreen BD

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer Radiology Class 2 892.2090 2021-12-16
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-02-17
QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer Radiology Class 2 892.2090 2026-02-17
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-11-14
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-02-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3016819165 THERAPIXEL Nice Alpes-Maritimes, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016759115. Last updated year: 2026. Please use registration number 3016759115 when referencing this establishment in official correspondence.
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