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

Stationary basic diagnostic x-ray system, digital

• 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