RADspeed Pro

GUDID 04540217071319

SHIMADZU CORPORATION

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 04540217071319
• NIH Device Record Key: bdebb2ca-4670-4552-b578-d0d2c16b3946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RADspeed Pro
• Version Model Number: 566-26000-50
• 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	04540217071319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233722

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: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [RADspeed Pro]

• 04540217059959: 503-79460-52
• 04540217059942: 503-79460-51
• 04540217052493: 503-79460-43
• 04540217052486: 503-79460-42
• 04540217052479: 503-79460-41
• 04540217052424: 503-79460-26
• 04540217052417: 503-79460-23
• 04540217052400: 503-79460-22
• 04540217052394: 503-79460-21
• 04540217052387: 503-79460-06
• 04540217052370: 503-79460-03
• 04540217052363: 503-79460-02
• 04540217052356: 503-79460-01
• 04540217040315: 503-77550-11
• 04540217040308: 503-77550-10
• 04540217040292: 503-77550-09
• 04540217060269: 503-79460-64
• 04540217060252: 503-79460-63
• 04540217060245: 503-79460-62
• 04540217060238: 503-79460-61
• 04540217060221: 503-79460-53
• 04540217071395: 566-26000-65
• 04540217071388: 566-26000-64
• 04540217071371: 566-26000-63
• 04540217071364: 566-26000-62
• 04540217071357: 566-26000-61
• 04540217071340: 566-26000-60
• 04540217071333: 566-26000-54
• 04540217071326: 566-26000-53
• 04540217071319: 566-26000-50