EPIQ Elite Ultrasound Circular Edition

GUDID 00884838113961

Software Version 9.x

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system

• Primary Device ID: 00884838113961
• NIH Device Record Key: c259ffb3-592c-4a0e-9b16-518c5c3c79e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIQ Elite Ultrasound Circular Edition
• Version Model Number: 795125
• 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: 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	00884838113961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211597

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: 2022-08-10
• Device Publish Date: 2022-08-02

Devices Manufactured by Philips Ultrasound, Inc.

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• 00884838123960 - EPIQ CVx Diagnostic Ultrasound System: 2024-06-06 VM11.0 Update
• 00884838123977 - EPIQ CVxi Diagnostic Ultrasound System: 2024-06-06 VM 11.0 Update
• 00884838123984 - Affiniti CVx Diagnostic Ultrasound System: 2024-06-06 VM11.0 update
• 00884838114265 - Affinti 30 Diagnostic Ultrasound System Circular Edition: 2024-06-04 VM10.0 Update
• 00884838114241 - Affinti 50 Diaagnostic Ultrasound System Circular Edition: 2024-05-13 Software Version 10.0.2
• 00884838114258 - Affinti 70 Diaagnostic Ultrasound System Circular Edition: 2024-05-13 Software Version 10.0.2
• 00884838114203 - EPIQ 7 Diagnostic Ultrasound System Circular Edition: 2024-04-18 10.0.X Circular Edition