SonoScope

GUDID 06945868699000

S9 Portable Digital Color Doppler Ultrasound System

SONOSCAPE MEDICAL CORP.

General-purpose ultrasound imaging system

• Primary Device ID: 06945868699000
• NIH Device Record Key: acc730a4-fc8c-46c2-a6b5-8be5c652ace3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SonoScope
• Version Model Number: S9
• Company DUNS: 545342185
• Company Name: SONOSCAPE MEDICAL CORP.
• 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: true
• 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	06945868699000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152165

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-19

Devices Manufactured by SONOSCAPE MEDICAL CORP.

• 06945868610135 - SonoScape: 2025-12-25 X11 Exp Digital Color Doppler Ultrasound System
• 06945868610142 - SonoScape: 2025-12-25 X11 Elite Digital Color Doppler Ultrasound System
• 06945868610159 - SonoScape: 2025-12-25 X11 Pro Digital Color Doppler Ultrasound System
• 06945868610166 - SonoScape: 2025-12-25 X11 Plus Digital Color Doppler Ultrasound System
• 06945868610173 - SonoScape: 2025-12-25 X11 Super Digital Color Doppler Ultrasound System
• 06945868610180 - SonoScape: 2025-12-25 X11 Senior Digital Color Doppler Ultrasound System
• 06945868610197 - SonoScape: 2025-12-25 X11 Digital Color Doppler Ultrasound System
• 06945868610203 - SonoScape: 2025-12-25 X11T Digital Color Doppler Ultrasound System