Vivid

Basic Information

• Brand Name: Vivid
• Primary DI: 00195278505170
• Version / Model: S70N v206CH
• Company Name: GE Vingmed Ultrasound AS
• Labeler DUNS: 518870571
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-12
• Public Version: 3
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: 9253a5a2-c0ad-4f9f-8758-b1cc6d228c93

Device Description

Vivid S70N v206 China

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, imaging, pulsed echo, ultrasonic	Radiology	892.1560	2
IYN	System, imaging, pulsed doppler, ultrasonic	Radiology	892.1550	2
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40763	Cardiovascular ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195278505170	GS1

Premarket Submissions

Submission Number	Supplement Number
K220619	000
K223832	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity