Ultrasound Workspace

GUDID 00884838129276

Device Model: 300013759461

Philips Ultrasound LLC

Radiological PACS software

• Primary Device ID: 00884838129276
• NIH Device Record Key: ec83459c-cbe6-4cd8-9a10-9c66666e2c9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound Workspace
• Version Model Number: 7.0.0.0
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838129276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241659

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: 2025-09-08
• Device Publish Date: 2025-08-29

On-Brand Devices [Ultrasound Workspace]

• 00884838125186: 6.0.2.0
• 00884838129276: Device Model: 300013759461