| Primary Device ID | 00842000100614 |
| NIH Device Record Key | 02a74744-f180-4c06-a1c8-b4fbefb1230e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RadSuite |
| Version Model Number | 8.32 |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842000100614 [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 | 2019-10-03 |
| Device Publish Date | 2019-09-25 |
| 00842000101215 - Merge PACS | 2025-09-11 |
| 00842000101208 - Merge PACS | 2025-08-28 |
| 00842000101222 - Merge Universal Viewer | 2025-08-11 |
| 00842000101178 - CADstream | 2024-11-22 Standalone software application |
| 00842000101079 - Merge Hemo | 2024-09-18 |
| 00842000101154 - Merge PACS | 2024-07-09 |
| 00842000101161 - Merge Universal Viewer | 2024-05-08 |
| 00842000101123 - Merge Cardio | 2024-02-13 Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management syste |