Incisive CT

GUDID 00884838085015

Philips Healthcare (Suzhou) Co., Ltd.

Full-body CT system

• Primary Device ID: 00884838085015
• NIH Device Record Key: 1132d7f7-9bf0-4915-a93c-147f8b8a7bb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Incisive CT
• Version Model Number: 728143
• Company DUNS: 421265537
• Company Name: Philips Healthcare (Suzhou) Co., Ltd.
• 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	00884838085015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180015

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [Incisive CT]

• 00884838085015: 728143
• 00884838105508: The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images