Ingenuity CT

GUDID 00884838059498

Philips Medical Systems Nederland B.V.

Full-body CT system

• Primary Device ID: 00884838059498
• NIH Device Record Key: ec0ac7bd-49e0-4fa5-b8b7-0bb132f08c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenuity CT
• Version Model Number: 728321
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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	00884838059498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160743

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2019-12-03
• Device Publish Date: 2016-09-23

On-Brand Devices [Ingenuity CT]

• 00884838059511: 728326
• 00884838059504: 728323
• 00884838059498: 728321