TOMTEC ARENA

GUDID 00884838124233

Philips Ultrasound LLC

Radiological PACS software

• Primary Device ID: 00884838124233
• NIH Device Record Key: 6b471d92-a672-4d4b-af3a-cacfa42145ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMTEC ARENA
• Version Model Number: TTA2.53
• Company DUNS: 063377717
• Company Name: Philips Ultrasound LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838124233 [Primary]

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2024-07-11
• Device Publish Date: 2024-07-03

Devices Manufactured by Philips Ultrasound LLC

• 00884838126893 - EPIQ Diagnostic Ultrasound System Circular Edition: 2025-07-01 EPIQ CVx Diagnostic Ultrasound System Circular Edition
• 00884838126909 - Affiniti CVx Diagnostic Ultrasound System: 2025-07-01 Affiniti CVx Diagnostic Ultrasound System
• 00884838126923 - EPIQ Diagnostic Ultrasound System: 2025-07-01 EPIQ CVx Diagnostic Ultrasound System
• 00884838126930 - EPIQ Diagnostic Ultrasound System: 2025-07-01 EPIQ CVxi Diagnostic Ultrasound System
• 00884838126947 - Affiniti CVx Diagnostic Ultrasound System Circular Edition: 2025-07-01 Affiniti CVx Diagnostic Ultrasound System Circular Edition
• 00884838115354 - Ultrasound System 5100 POC: 2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
• 00884838120174 - Ultrasound System 5100 POC Pro: 2025-05-29 Flash Ultrasound System 5100 POC, release 1.0.
• 00884838125186 - Ultrasound Workspace: 2025-04-01