Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026753394

FEI Number

3026753394

Entity Name

AZMED SAS

City/State/Country

Paris, FR

Establishment Address

10 Rue D'Uzes, Paris 75002, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

AZmed (Owner Number: 10087096)

Owner / Operator Contact Address

10 Rue d'Uzes, Paris, FR-IDF 75002, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243831

PMA Number

N/A

All Registered Proprietary Names

Rayvolve Rayvolve Rayvolve PTX-PE Rayvolve Rayvolve LN

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	2023-01-24
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Radiology	Class 2	892.2090	2024-10-09
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2026-04-15
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Radiology	Class 2	892.2090	2026-06-01
MYN	Analyzer, Medical Image	Radiology	Class 2	892.2070	2026-04-15

Official Correspondent

Anthony JOSEPH

US Agent Details

Michelle Lott Business: leanRAQA Email: michelle@leanraqa.com Phone: (520) 2759838

Related Public Records

Same Entity

AZmed

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

Similar Registrations

Registration Number	Establishment Name	Location
3014661828	IMAGEN TECHNOLOGIES, INC.	New York, NY, US
9616047	GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.	APODACA Nuevo Leon, MX
3027453703	MILVUE	Paris Ile-de-France, FR
3021907554	GLEAMER	Paris Ile-de-France, FR
2126677	GE MEDICAL SYSTEMS, LLC	Waukesha, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026753394. Last updated year: 2026. Please use registration number 3026753394 when referencing this establishment in official correspondence.