INHEART

FDA Device Registration & Listing · Pessac Gironde, FR · Registration 3018302800

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
3018302800
FEI Number
3018302800
Entity Name
INHEART
City/State/Country
Pessac Gironde, FR
Establishment Address
IHU Liryc - Hopital Xavier Arnozan, Avenue du Haut Leveque, Pessac Gironde 33600, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
inHEART (Owner Number: 10081210)
Owner / Operator Contact Address
IHU Liryc - Hopital Xavier Arnozan, Avenue du Haut Leveque, Pessac, FR-33 33600, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231683
PMA Number
N/A

All Registered Proprietary Names

inHEART MODELS

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 2024-03-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-03-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Gareau Business: inHEART Inc Email: david.gareau@inheartmedical.com Phone: (609) 7131865

Related Public Records

Same Entity

inHEART
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
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
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

Registration Number Establishment Name Location
3042928350 Computer Vision AG Wallisellen Zurich, CH
3021027284 ANGIOWAVE IMAGING, INC. Concord, MA, US
3030088963 REBRAIN PESSAC Gironde, FR
3042852277 REMEDY LOGIC New York, NY, US
3027986210 MRIGUIDANCE B.V. Utrecht, NL
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018302800. Last updated year: 2026. Please use registration number 3018302800 when referencing this establishment in official correspondence.
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