EPIQ 5G ULTRASOUND SYSTEM

GUDID 00884838097896

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 00884838097896
• NIH Device Record Key: 08b70091-8350-47d2-8b60-1f96be1f0488
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIQ 5G ULTRASOUND SYSTEM
• Version Model Number: 795204
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, Inc.
• 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: true
• Serial Number: false
• 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	00884838097896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200304

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: 2020-08-24
• Device Publish Date: 2020-08-14

Devices Manufactured by Philips Ultrasound, Inc.

• 00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114210 - EPIQ 5 Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114227 - EPIQ CVx Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838114234 - EPIQ Elite Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition
• 00884838102729 - Transducer X11-4t: 2024-04-11
• 00884838115323 - QLAB Advanced Quantification Software: 2024-04-11
• 00884838122116 - Lumify Diagnostic Ultrasound System: 2024-04-08 Android 5.0
• 00884838120266 - Lumify Diagnostic Ultrasound System iOS: 2023-08-08 Release 5.0 iOS