FDR Visionary Suite

GUDID 04540217071586

SHIMADZU CORPORATION

Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 04540217071586
• NIH Device Record Key: 4290a8b6-7815-418d-803f-39ec1ac1fca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDR Visionary Suite
• Version Model Number: 566-16130-80
• Company DUNS: 690558747
• Company Name: SHIMADZU 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: true
• 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	04540217071586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233719

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: 2024-06-03
• Device Publish Date: 2024-05-24

On-Brand Devices [FDR Visionary Suite]

• 04540217057450: 566-16130-33
• 04540217057443: 566-16130-32
• 04540217057436: 566-16130-31
• 04540217052226: 566-16130-23
• 04540217052219: 566-16130-22
• 04540217052202: 566-16130-21
• 04540217064724: 566-16130-63
• 04540217064717: 566-16130-62
• 04540217064700: 566-16130-53
• 04540217064694: 566-16130-52
• 04540217071616: 566-16130-83
• 04540217071609: 566-16130-82
• 04540217071593: 566-16130-81
• 04540217071586: 566-16130-80