DLIR 5928863

GUDID 00195278620453

SWMD DLIR Application for Smart Subscription

GE HEALTHCARE JAPAN CORPORATION

CT system application software

• Primary Device ID: 00195278620453
• NIH Device Record Key: 24f27b81-dc16-445a-92c3-e395735414d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DLIR
• Version Model Number: 1.2
• Catalog Number: 5928863
• Company DUNS: 696021596
• Company Name: GE HEALTHCARE JAPAN CORPORATION
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278620453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230807

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: 2023-07-10
• Device Publish Date: 2023-06-30

On-Brand Devices [DLIR]

• 00840682146586: 1.0
• 00195278303202: DLIR Application Container for Smart Subscription
• 00195278620453: SWMD DLIR Application for Smart Subscription