AXIR-CX AXIR-CX

GUDID 08800099500076

Radiological Image Processing System

Radisen Co., Ltd.

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 08800099500076
• NIH Device Record Key: b5f3eee3-9bb7-4608-ac62-76a6fd492e05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AXIR-CX
• Version Model Number: AXIR-CX
• Catalog Number: AXIR-CX
• Company DUNS: 694770428
• Company Name: Radisen Co., Ltd.
• Device Count: 1
• DM Exempt: true
• 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	08800099500076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213520

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-11-23
• Device Publish Date: 2023-11-15

Devices Manufactured by Radisen Co., Ltd.

• 08800099500007 - PEDRA: 2023-11-23 Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500014 - PEDRA: 2023-11-23 Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500021 - PEDRA: 2023-11-23 Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500038 - PEDRA: 2023-11-23 Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500045 - PEDRA: 2023-11-23 Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500052 - PEDRA: 2023-11-23 Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500069 - PEDRA: 2023-11-23 Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
• 08800099500076 - AXIR-CX: 2023-11-23Radiological Image Processing System
• 08800099500076 - AXIR-CX: 2023-11-23 Radiological Image Processing System