TOMTEC ARENA 795130

GUDID 00884838121423

Philips Ultrasound, Inc.

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 00884838121423
• NIH Device Record Key: 46cae9e1-daa7-4f5d-9ba9-2838bee532b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOMTEC ARENA
• Version Model Number: TTA2
• Catalog Number: 795130
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838121423 [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: 2023-07-27
• Device Publish Date: 2023-07-19

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