Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030446846

FEI Number

3030446846

Entity Name

MYCARDIUM AI LTD

City/State/Country

Liverpool, GB

Establishment Address

The Spine Building, 2 Paddington Village, Liverpool L73FA, GB

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Mycardium AI Ltd (Owner Number: 10089951)

Owner / Operator Contact Address

The Spine Building, 2 Paddington Village, Liverpool, GB-LIV L73FA, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242062

PMA Number

N/A

All Registered Proprietary Names

EchoConfidence 1CMR Lite 1CMR Pro

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	2025-07-09
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2024-01-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-11-29
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-11-29

Official Correspondent

Ranjitha Byatha Kemparaj

US Agent Details

Stephen Lieberman Business: Donawa Lifescience Inc. Email: lieberman@donawa.com Phone: (561) 3020777

Related Public Records

Same Entity

Mycardium AI Ltd

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 3030446846. Last updated year: 2026. Please use registration number 3030446846 when referencing this establishment in official correspondence.