| Primary Device ID | 04250802900015 |
| NIH Device Record Key | b9a5e0bb-25ce-4d8a-8b27-841fcad275b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | dicomPACS®DX-R |
| Version Model Number | 8 |
| 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 | 04250802900015 [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 | 2023-12-21 |
| Device Publish Date | 2023-12-13 |
| 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 |