Consona N6T Diagnostic Ultrasound System

GUDID 06903053012515

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

General-purpose ultrasound imaging system

• Primary Device ID: 06903053012515
• NIH Device Record Key: 9709ef31-cb6e-45d8-9774-33d96cc9c9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consona N6T Diagnostic Ultrasound System
• Version Model Number: Consona N6T
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06903053012515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221496

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2025-02-17
• Device Publish Date: 2025-02-07

Devices Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

• 06944904064659 - DC-30: 2025-02-18
• 06944904099781 - DC-25: 2025-02-18
• 06944904099798 - DC-26: 2025-02-18
• 06944904099804 - DC-28: 2025-02-18
• 06944904099811 - DC-32: 2025-02-18
• 06903053012355 - Consona AE Diagnostic Ultrasound System: 2025-02-17
• 06903053012379 - Consona AR Diagnostic Ultrasound System: 2025-02-17
• 06903053012386 - Consona AT Diagnostic Ultrasound System: 2025-02-17