Q-Station

GUDID 00884838078079

Philips Ultrasound, Inc.

Radiology PACS software

• Primary Device ID: 00884838078079
• NIH Device Record Key: bf536474-823d-400f-b0a9-467b9bfe7448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Station
• Version Model Number: Release 3.7
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838078079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140808

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-02-01

On-Brand Devices [Q-Station]

• 00884838086623: Release 3.8.5
• 00884838085800: 989605382391
• 00884838078079: Release 3.7