RADspeed fit

GUDID 04540217060016

SHIMADZU CORPORATION

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 04540217060016
• NIH Device Record Key: 75578392-702a-47c4-847c-787efe218ced
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADspeed fit
• Version Model Number: 566-12700-32
• 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	04540217060016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173517

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-07

On-Brand Devices [RADspeed fit]

• 04540217060016: 566-12700-32
• 04540217059980: 566-12700-22
• 04540217062621: 566-12700-75
• 04540217062577: 566-12700-65