s5i Imaging System

GUDID 00845225010218

VOLCANO CORPORATION

Cardiovascular ultrasound imaging system

• Primary Device ID: 00845225010218
• NIH Device Record Key: be7c690b-2c2c-4224-8bb7-9ef6624358ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s5i Imaging System
• Version Model Number: 807400001
• Company DUNS: 135179237
• Company Name: VOLCANO 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845225010218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071554

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

Devices Manufactured by VOLCANO CORPORATION

• 20845225012681 - SpinVision STERILE EQUIPEMENT COVER: 2021-10-26
• 20845225012698 - DIGITAL IVUS STERILE EQUIPEMENT COVER: 2021-10-26
• 10845225012707 - R-100 STERILE EQUIPEMENT COVER: 2021-10-26
• 00845225012915 - IntraSight Mobile: 2021-02-03
• 00845225012847 - FM-PIM: 2021-01-29
• 00845225012656 - CORE FM CART: 2020-06-02
• 00845225010874 - ComboMap Pressure and Flow System: 2020-01-01
• 00845225002565 - Pioneer Plus Catheter: 2019-03-21