dicomPACS(R) ORCA OC1000

GUDID 04250802900169

Cloud based DICOM picture archiving system

Oehm und Rehbein GmbH

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software 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