AcuityDRe

GUDID 00810035220447

RADMEDIX, LLC

Indirect flat panel x-ray detector

• Primary Device ID: 00810035220447
• NIH Device Record Key: 3f593321-b6b5-4234-8ace-38d200262d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuityDRe
• 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: false
• 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	00810035220447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210919

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

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

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

[00810035220447]

Liquid Chemical

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-01
• Device Publish Date: 2021-05-24

Devices Manufactured by RADMEDIX, LLC

• 00810035220522 - Radmedix AcuityUDR: 2023-12-26 RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, gen
• 00810035220492 - Radmedix AcuityDR 1717 G4: 2023-07-28 AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography pan
• 00810035220508 - Radmedix AcuityDR 1417 G4: 2023-07-28 AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography pan
• 00810035220515 - Radmedix AcuityDR 1013 G4: 2023-07-28 AcuityDR G4 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography pan
• 00810035220478 - Radmedix AcuityDRe 1417w: 2022-11-10
• 00810035220485 - Radmedix AcuityDRe 1717w: 2022-11-10
• 00810035220454 - Radmedix AcuityUDR: 2021-12-07
• 00810035220461 - Radmedix AcuityPDR+: 2021-12-07