X-RAY FLAT PANEL DETECTOR

GUDID 04987670104312

CANON MEDICAL SYSTEMS CORPORATION

Indirect flat panel x-ray detector

• Primary Device ID: 04987670104312
• NIH Device Record Key: f42894c0-fd67-4361-873d-b1d43cfcbc0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-RAY FLAT PANEL DETECTOR
• Version Model Number: TFP-1216C
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670104312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233107

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2025-03-11
• Device Publish Date: 2025-03-03

On-Brand Devices [X-RAY FLAT PANEL DETECTOR]

• 04987670104312: TFP-1216C
• 04987670100345: TFP-1216A