MELODY

Primary DI: 03770015437012
Brand: MELODY
Company: ADVANCED ECHO TECHNOLOGY
Model: MELODY PATIENT
Published: 2022-01-24
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: MR Unsafe
Rx: true
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

adechotech.com

Product Codes

Code	Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications

Code	Device	Specialty	Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	2

Premarket Submissions

Submission	Supplement
K161354	000

Premarket Details

Submission	Supplement	Device	Applicant	Decision date	Product code
K161354	000	MELODY, Remote Control System for Ultrasound Probe	Adecho Tech	2017-06-12	IYO

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
03770015437012	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
03770015437012	03770015437012	3770015437012

GMDN Terms

Term	Definition
Video consultation telemedicine system	A electrically-powered device designed for use in telemedicine to provide real-time and interactive transmission of images and sound between two or more sites, enabling a healthcare professional to communicate with other professionals or directly with a patient. It consists of VDU, camera, speaker, and headphone components that may be integrated (or attached to) a mobile or hand-held unit which has rechargeable batteries, or as components that can be connected to a television; there may be optional accessories to provide additional functionality (e.g., stethoscope). It can be used within or between healthcare facilities, or a professional facility and the home.

Term

Definition

Video consultation telemedicine system

A electrically-powered device designed for use in telemedicine to provide real-time and interactive transmission of images and sound between two or more sites, enabling a healthcare professional to communicate with other professionals or directly with a patient. It consists of VDU, camera, speaker, and headphone components that may be integrated (or attached to) a mobile or hand-held unit which has rechargeable batteries, or as components that can be connected to a television; there may be optional accessories to provide additional functionality (e.g., stethoscope). It can be used within or between healthcare facilities, or a professional facility and the home.

Sterilization Methods

Method

Contacts

Phone	Email
+33967174746	info@adechotech.com

Regulatory Flags

DUNS number: 260110102
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: false
Serial number: true
Manufacturing date on label: false
Expiration date on label: false
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: true
Sterilization required before use: false

Other Devices From This Company

Primary DI	Brand	Model	Catalog	Published
03770015437029	MELODY	MELODY EXPERT		2022-01-24

Other Devices Sharing Product Codes

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00198953042816	LOGIQ	Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc	IYO	2025-12-05
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16978669290005	Astrasono A3Pro Bladder Scanner	Astrasono technology co.,ltd.	IYO	2025-11-20
00198953001431	Venue Go	Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc	IYO	2025-11-17
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06938396401030	SIUI	Shantou Institute of Ultrasonic Instruments Co., Ltd.	IYO	2025-07-21
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