QLAB Advanced Quantification Software

GUDID 00884838091672

Philips Ultrasound, Inc.

Radiology PACS software

• Primary Device ID: 00884838091672
• NIH Device Record Key: f64ffdf0-7ddb-4868-8f3f-163fcf90efc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QLAB Advanced Quantification Software
• Version Model Number: 989605496481
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	00884838091672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190913

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: 2
• Public Version Date: 2020-03-16
• Device Publish Date: 2019-06-27

On-Brand Devices [QLAB Advanced Quantification Software]

• 00884838090736: 989605492681
• 00884838084322: 989605465051
• 00884838091672: 989605496481
• 00884838103603: Software Revision 15.5
• 00884838115323: Release 15.6
• 00884838122277: VM11.0 update