SIUI

GUDID 06938396400422

Portable DR Imaging System

Shantou Institute of Ultrasonic Instruments Co., Ltd.

Portable basic diagnostic x-ray system, digital

• Primary Device ID: 06938396400422
• NIH Device Record Key: d3e11096-e7a5-499c-81ce-6bd183cad733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIUI
• Version Model Number: SR-1100S
• Company DUNS: 654090299
• Company Name: Shantou Institute of Ultrasonic Instruments Co., Ltd.
• 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: true
• 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	06938396400422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202350

FDA Product Code

• IZL: System, X-Ray, Mobile

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: 2021-12-28
• Device Publish Date: 2021-12-20

On-Brand Devices [SIUI]

• 06938396495084: Volume Probe
• 06938396495053: Convex Array Transducer
• 06938396495046: Convex Array Transducer
• 06938396495022: Convex Array Transducer
• 06938396494056: Phased Array Transducer
• 06938396494049: Phased Array Transducer
• 06938396494032: Phased Array Transducer
• 06938396494018: Phased Array Transducer
• 06938396493301: Endocavity BiplaneTransducer
• 06938396493295: Endocavity Transducer
• 06938396493288: Endocavity Transducer
• 06938396493189: Endocavity Transducer
• 06938396493172: Endocavity Transducer
• 06938396492250: Micro-Convex Array Transducer
• 06938396492205: Convex Array Transducer
• 06938396491321: Endocavity BiplaneTransducer
• 06938396491314: Endocavity BiplaneTransducer
• 06938396491307: Linear Array Transducer
• 06938396491291: Linear Array Transducer
• 06938396491208: Linear Array Transducer
• 06938396491192: Linear Array Transducer
• 06938396491147: Linear Array Transducer
• 06938396491116: Linear Array Transducer
• 06938396491055: Linear Array Transducer
• 06938396491024: Linear Array Transducer
• 06938396490256: Convex Array Transducer
• 06938396490171: Convex Array Transducer
• 06938396490126: Convex Array Transducer
• 06938396490096: Convex Array Transducer
• 06938396490065: Convex Array Transducer
• 06938396490041: Convex Array Transducer
• 06938396488017: Digital Color Doppler Ultrasound Imaging System
• 06938396488000: Digital Ultrasound Imaging System
• 06938396477011: Digital Color Doppler Ultrasound Imaging System
• 06938396477004: Digital Ultrasound Imaging System
• 06938396466008: Diagnostic Ultrasound Imaging System
• 06938396458003: Digital Color Doppler Ultrasound Imaging System
• 06938396455019: Digital Color Doppler Ultrasound Imaging System
• 06938396455002: Diagnostic Ultrasound Imaging System
• 06938396453008: Digital Color Doppler Ultrasound Imaging System
• 06938396438005: Digital Color Doppler Ultrasound Imaging System
• 06938396435004: Digital Color Doppler Ultrasound Imaging System
• 06938396433017: Diagnostic Ultrasound Imaging System
• 06938396431020: Ultrasound Imaging System
• 06938396423001: Digital Color Doppler Ultrasound Imaging System
• 06938396421007: Digital Color Doppler Ultrasound Imaging System
• 06938396412005: Digital Color Doppler Ultrasound Imaging System
• 06938396411008: Digital Color Doppler Ultrasound Imaging System
• 06938396410001: Digital Color Doppler Ultrasound Imaging System
• 06938396409005: Digital Ultrasound Imaging System