dicomPACS(R) ORCA OC1000

GUDID 04250802900169

Cloud based DICOM picture archiving system

Oehm und Rehbein GmbH

Radiology DICOM image processing application software

• Primary Device ID: 04250802900169
• NIH Device Record Key: 37338eed-7fe2-49ab-9b41-874e85a56632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dicomPACS(R) ORCA
• Version Model Number: 5
• Catalog Number: OC1000
• 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: false
• Expiration Date: false
• Donation Id Number: true
• 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	04250802900169 [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: 2023-12-21
• Device Publish Date: 2023-12-13

Devices Manufactured by Oehm und Rehbein GmbH

• 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: 2023-12-21Cloud based DICOM picture archiving system
• 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
• 04250802900411 - 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
• 04250802900800 - dicomPACS: 2019-10-07 DICOM picture archiving system