ARIETTA 650

GUDID 04573596214381

Diagnostic Ultrasound System

FUJIFILM HEALTHCARE CORPORATION

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 04573596214381
• NIH Device Record Key: 4c14fd47-cc71-458b-858c-9f3f8281d0df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIETTA 650
• Version Model Number: ARIETTA 650
• Company DUNS: 718262719
• Company Name: FUJIFILM HEALTHCARE CORPORATION
• 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: 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	04573596214381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181376

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: 2022-02-15
• Device Publish Date: 2022-02-07

Devices Manufactured by FUJIFILM HEALTHCARE CORPORATION

• 04573596212011 - L31KP: 2024-02-02 Probe
• 04573596212318 - S3ESCLS: 2024-02-02 Probe
• 04573596212035 - L35: 2024-01-30 Probe
• 04573596212455 - UST-2266-5: 2024-01-30 Probe
• 04573596214176 - CL4416R1: 2024-01-30 Probe
• 04573596214336 - C421: 2024-01-30 Probe
• 04573596214503 - CC41R2: 2024-01-30 Probe
• 04573596214510 - C253A: 2024-01-30 Probe