dicomPACS®DX-R SW1000

GUDID 04250802900404

Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.

Oehm und Rehbein GmbH

Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software Basic diagnostic x-ray system application software

• Primary Device ID: 04250802900404
• NIH Device Record Key: 050ec292-3576-4160-bb33-9271c35cfe0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dicomPACS®DX-R
• Version Model Number: 4.3
• Catalog Number: SW1000
• Company DUNS: 344349290
• Company Name: Oehm und Rehbein GmbH
• 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: true
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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	04250802900404 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-03-22

On-Brand Devices [dicomPACS®DX-R]

• 04250802900411: Professional acquisition software for the connection and control of a direct radiography detecto
• 04250802900404: Professional acquisition software for the connection and control of a direct radiography detecto
• 04250802900015: Professional acquisition software for the connection and control of a direct radiography detecto