Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016819165

FEI Number

3016819165

Entity Name

THERAPIXEL

City/State/Country

Nice Alpes-Maritimes, FR

Establishment Address

455 Promenade des Anglais, Nice Alpes-Maritimes 06200, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

THERAPIXEL (Owner Number: 10071453)

Owner / Operator Contact Address

1 Impasse Reille, Paris, FR-75 75014, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211541

PMA Number

N/A

All Registered Proprietary Names

Genius AI Detection PRO Density MammoScreen BD Genius AI Detection PRO Image Quality for Quality MammoScreen QC MammoScreen MammoScreen 3 Genius AI® Detection PRO MammoScreen® 3 MammoScreen® MammoScreen® MammoScreen® 4 Genius AI® Detection PRO MammoScreen MammoScreen 4 Genius AI Detection PRO Density MammoScreen BD MammoScreen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-11-14
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2024-11-14
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2024-08-19
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-08-19
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	2026-02-17
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2021-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Alex Cadotte Business: VP, Digital Health, AI and Radiology Email: acadotte@mcra.com Phone: (347) 3024549

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
3016759115	Therapixel Inc.	Chicago, IL, US

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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3030088963	REBRAIN	PESSAC Gironde, FR
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016819165. Last updated year: 2026. Please use registration number 3016819165 when referencing this establishment in official correspondence.