| Primary Device ID | 00860011623915 |
| NIH Device Record Key | 6647ee13-34db-4b89-9bd9-a6f41ec17687 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Torana™ |
| Version Model Number | 2.18.2 |
| Company DUNS | 746985634 |
| Company Name | SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 | 00860011623915 [Primary] |
| LMD | System, Digital Image Communications, 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 | 2024-05-30 |
| Device Publish Date | 2024-05-22 |
| 00860011623908 - iQ-solutions™ | 2024-05-30 iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable |
| 00860011623915 - Torana™ | 2024-05-30The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server. |
| 00860011623915 - Torana™ | 2024-05-30 The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health in |