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 |
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 |
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 |
00842000101093 - Merge Universal Viewer | 2023-03-27 |