EPIQ Elite Diagnostic Ultrasound System

GUDID 00884838124912

EPIQ Elite Diagnostic Ultrasound System VM 12.0.

Philips Ultrasound LLC

General-purpose ultrasound imaging system

• Primary Device ID: 00884838124912
• NIH Device Record Key: 2c8020e4-03be-478e-aa0c-ced4dda3587f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIQ Elite Diagnostic Ultrasound System
• Version Model Number: 795234
• 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	00884838124912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242020

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: 2024-12-27
• Device Publish Date: 2024-12-19

Devices Manufactured by Philips Ultrasound LLC

• 00884838124912 - EPIQ Elite Diagnostic Ultrasound System: 2024-12-27EPIQ Elite Diagnostic Ultrasound System VM 12.0.
• 00884838124912 - EPIQ Elite Diagnostic Ultrasound System: 2024-12-27 EPIQ Elite Diagnostic Ultrasound System VM 12.0.
• 00884838124974 - Affiniti 30 Ultrasound System: 2024-12-27 Affiniti 30 Ultrasound System VM 12.0
• 00884838124981 - Affiniti 50 Ultrasound System: 2024-12-27 VM12.0
• 00884838124998 - Affiniti 70 Ultrasound System: 2024-12-27 VM12.0
• 00884838109995 - EPIQ 7C Diagnostic Ultrasound System Circular Edition: 2024-08-19 VM 11.0 update
• 00884838100213 - Transducer C5-1: 2024-08-07 Introduction of C5-1 (Shanghai Version) to rest of the world.
• 00884838124233 - TOMTEC ARENA: 2024-07-11
• 00884838125674 - Affiniti CVx Diagnostic Ultrasound System Circular Edition: 2024-06-20 VM 11.0 update