DIAGNOLY

FDA Device Registration & Listing · Lyon 3e Arrondissement Rhone, FR · Registration 3033557977

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
3033557977
FEI Number
3033557977
Entity Name
DIAGNOLY
City/State/Country
Lyon 3e Arrondissement Rhone, FR
Establishment Address
Immeuble Terra Mundi, 2 Place De Francfort, Lyon 3e Arrondissement Rhone 69003, FR
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
DIAGNOLY (Owner Number: 10091679)
Owner / Operator Contact Address
2 place de Francfort, Bat.Terra Mundi, LYON, FR-69 69003, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251368
PMA Number
N/A

All Registered Proprietary Names

FETOLY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-09-15
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-09-15
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-09-15

Official Correspondent

No official correspondent registered.

US Agent Details

Mindy McCann Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

DIAGNOLY
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
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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3012081348 THE SENTINEL IMAGING GROUP, INC Clarks Summit, PA, US
3025786376 ACO HEALTHCARE CO., LTD. Taoyuan City, TW
3004752776 Compumedics Germany GmbH Singen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033557977. Last updated year: 2026. Please use registration number 3033557977 when referencing this establishment in official correspondence.
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