FDR Visionary Suite

GUDID 04540217052226

SHIMADZU CORPORATION

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 04540217052226
• NIH Device Record Key: 5b06da02-3c8b-40f3-87a7-7d2b560591bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDR Visionary Suite
• Version Model Number: 566-16130-23
• 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: true
• 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	04540217052226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152294

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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