UST 5550-R

GUDID 00860007188312

Ultrasound Robotic Probe

HITACHI HEALTHCARE AMERICAS CORPORATION

Surgical ultrasound imaging transducer

• Primary Device ID: 00860007188312
• NIH Device Record Key: ca7430a6-f277-4609-bea4-fbd82047cc88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UST 5550-R
• Version Model Number: UST 5550-R
• Company DUNS: 603156043
• Company Name: HITACHI HEALTHCARE AMERICAS 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007188312 [Primary]
GS1	00869047000400 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122537

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

[00860007188312]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

Devices Manufactured by HITACHI HEALTHCARE AMERICAS CORPORATION

• 00860007188305 - C9150LA: 2021-07-09 4-way Laparoscopic Ultrasound Transducer/Smart Connector
• 00860007188312 - UST 5550-R: 2021-07-09Ultrasound Robotic Probe
• 00860007188312 - UST 5550-R: 2021-07-09 Ultrasound Robotic Probe
• 00860007188329 - UST-9150: 2021-07-09 Ultrasound Laparoscopic Probe
• 00860007188336 - UST-52114P-B: 2021-07-09 Ultrasound Brainpath Probe
• 00869047000455 - D&K Technologies: 2021-02-23 System Arm, Stabilizer, Stepper & Stand
• 00869047000462 - D&K Technologies: 2021-02-23 System Arm, Stabilizer, Stepper & Stand
• 00869047000448 - HITACHI HEALTHCARE AMERICAS: 2020-07-07 Ultrasound transducer
• 00869047000431 - VidiStar PACS & DICOM Viewer Software: 2019-05-23 The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as