EPIQ CVx Diagnostic Ultrasound System Circular Edition

GUDID 00884838125643

VM11.0 update

Philips Ultrasound LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00884838125643
• NIH Device Record Key: 22ad0df3-922f-4c77-b476-39ebc2caa0cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIQ CVx Diagnostic Ultrasound System Circular Edition
• Version Model Number: 795122
• Company DUNS: 063377717
• Company Name: Philips Ultrasound LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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	00884838125643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233545

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, 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: 2024-06-11
• Device Publish Date: 2024-06-03

Devices Manufactured by Philips Ultrasound LLC

• 00884838124233 - TOMTEC ARENA: 2024-07-11
• 00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition: 2024-06-20 VM 11.0 update
• 00884838125643 - EPIQ CVx Diagnostic Ultrasound System Circular Edition: 2024-06-11VM11.0 update
• 00884838125643 - EPIQ CVx Diagnostic Ultrasound System Circular Edition: 2024-06-11 VM11.0 update
• 00884838125650 - EPIQ 7 Diagnostic Ultrasound System Circular Edition: 2024-06-11 VM11.0 update
• 00884838125667 - Affiniti 70 Diagnostic Ultrasound System Circular Edition: 2024-06-11 VM11.0 update