QLAB Quantification Software

GUDID 00884838059788

Philips Ultrasound, Inc.

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: 00884838059788
• NIH Device Record Key: 7bb6c619-e21f-4a19-a105-cfa52c34fd3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QLAB Quantification Software
• Version Model Number: Release 10.5
• 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	00884838059788 [Primary]

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: 4
• Public Version Date: 2019-05-23
• Device Publish Date: 2016-03-31

On-Brand Devices [QLAB Quantification Software]

• 00884838086616: Release 10.8.5
• 00884838070837: Release 10.7
• 00884838059788: Release 10.5
• 00884838098220: 989606710071