| Primary Device ID | 00842000100683 |
| NIH Device Record Key | dc729b74-71f2-43c7-83df-c17c8adcd182 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iConnect Access |
| Version Model Number | 6.5 |
| Company DUNS | 065626069 |
| Company Name | MERGE HEALTHCARE SOLUTIONS INC. |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00842000100683 [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 | 2019-05-20 |
| Device Publish Date | 2019-05-10 |
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| 00842000101154 - Merge PACS | 2024-07-09 |
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| 00842000101147 - Merge PACS | 2023-12-06 |
| 00842000101086 - Merge PACS | 2023-09-22 |
| 00842000101130 - Merge Universal Viewer | 2023-09-07 |
| 00842000100904 - Merge OrthoTemplates | 2023-06-19 Software implant template |