| Primary Device ID | 04250802900206 |
| NIH Device Record Key | cd7c64c4-b066-48e0-aaa8-36bfc4f7c8f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | dicomPACS®DX-R |
| Version Model Number | 9 |
| 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 | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04250802900206 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
| 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 |
| 04250802900206 | 9 |