Radmedix AcuityUDR

GUDID 00810035220522

RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software. 21CFR 892.1680 Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

RADMEDIX, LLC

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• Primary Device ID: 00810035220522
• NIH Device Record Key: 0016986d-7270-4805-8b02-4ae0948005af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radmedix AcuityUDR
• Version Model Number: 1
• Company DUNS: 005057263
• Company Name: RADMEDIX, LLC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810035220522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231995

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

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

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

[00810035220522]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-26
• Device Publish Date: 2023-12-18

On-Brand Devices [Radmedix AcuityUDR]

• 00810035220454: 1
• 00810035220522: RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube s