Kosmos OTS Android Linear Color

GUDID 09353278000694

Kosmos on Android software application for ultrasound imaging

ECHONOUS, INC.

Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software Ultrasound imaging system application software

• Primary Device ID: 09353278000694
• NIH Device Record Key: b48ca950-a0d2-4323-b3ee-bdc038622fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kosmos OTS Android Linear Color
• Version Model Number: P007465
• Company DUNS: 080481089
• Company Name: ECHONOUS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09353278000694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193518

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-14
• Device Publish Date: 2022-09-06

Devices Manufactured by ECHONOUS, INC.

• 09353278000762 - Kosmos OTS iOS: 2024-05-14 KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
• 09353278000632 - Kosmos Power Pack: 2023-03-20 Kosmos Power Pack
• 09353278000724 - Kosmos Power Pack (Refurbished): 2023-03-20 Kosmos Power Pack (Refurbished)
• 09353278000663 - EchoNous Samsung S8 Tablet with Software: 2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software
• 09353278000670 - EchoNous Samsung S8 Tablet with Software (Refurbished): 2023-03-16 EchoNous (Uscan) Samsung S8 Tablet with Software (Refurbished)
• 09353278000717 - Kosmos OTS iOS Software Package: 2023-03-14 Kosmos OTS iOS Software Package
• 09353278000700 - Kosmos OTS Android Doppler Software Package: 2023-02-13 Kosmos OTS Android Doppler Software Package
• 09353278000687 - Kosmos OTS Android Linear: 2022-09-14 Kosmos on Android software application for ultrasound imaging