CORE Series Precision Guided Therapy System

GUDID 00845225012670

VOLCANO CORPORATION

Cardiovascular ultrasound imaging system

• Primary Device ID: 00845225012670
• NIH Device Record Key: a0ab2490-f78c-4a5b-9fb3-8b6e9f4feadc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORE Series Precision Guided Therapy System
• Version Model Number: S18081AA
• 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	00845225012670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113486

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

On-Brand Devices [CORE Series Precision Guided Therapy System]

• 00845225012670: S18081AA
• 00845225010300: 400-0100.02