AccessGUDID - DEVICE: Mycardium (05061038730050)

GUDID

Device Identifier (DI) Information

Brand Name: Mycardium
Version or Model: 01.01.00(USA)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EchoConfidence
Company Name: MYCARDIUM AI LIMITED

Primary DI Number: 05061038730050
Issuing Agency: GS1
Commercial Distribution End Date: July 09, 2032
Device Count: 1
Labeler D-U-N-S® Number*: 228840878 *Terms of Use

Device Description: EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44783	Cardiac mapping system application software	An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIH	Automated Radiological Image Processing Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K250670	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4a0410c3-5132-4920-aae4-f966c6318c1a
Public Version Date: July 21, 2025
Public Version Number: 1
DI Record Publish Date: July 11, 2025