dicomPACS® L1000

GUDID 04250802900183

Oehm und Rehbein GmbH

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: 04250802900183
• NIH Device Record Key: 9a55464b-d5dd-4f20-b9ab-cca6fe2969e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dicomPACS®
• Version Model Number: 12
• Catalog Number: L1000
• 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: false
• Single Use: false
• Lot Batch: true
• 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	04250802900183 [Primary]

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: 2025-08-26
• Device Publish Date: 2025-08-18

Devices Manufactured by Oehm und Rehbein GmbH

• 04250802900183 - dicomPACS®: 2025-08-26
• 04250802900183 - dicomPACS®: 2025-08-26
• 04250802900206 - dicomPACS®DX-R: 2025-08-26
• 04250802900008 - Amadeo M-DR mini: 2023-12-21 The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency
• 04250802900015 - dicomPACS®DX-R: 2023-12-21 Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphi
• 04250802900022 - dicomPACS: 2023-12-21 DICOM picture archiving system
• 04250802900039 - dicomPACS(R) MobileView: 2023-12-21 DICOM picture mobile viewer
• 04250802900169 - dicomPACS(R) ORCA: 2023-12-21 Cloud based DICOM picture archiving system
• 04250802900404 - dicomPACS®DX-R: 2019-10-07 Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphi