FLUOROspeed

GUDID 04540217065271

SHIMADZU CORPORATION

Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 04540217065271
• NIH Device Record Key: 66b194c4-3cb9-4081-aad0-cd2ae9d7d331
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLUOROspeed
• Version Model Number: 566-23000-03
• 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	04540217065271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191877

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2021-08-30
• Device Publish Date: 2021-08-20

On-Brand Devices [FLUOROspeed]

• 04540217061716: 566-23000-01
• 04540217061723: 566-23000-02
• 04540217065271: 566-23000-03