| Primary Device ID | 00896100002002 |
| NIH Device Record Key | 896f8bdc-cc5c-49b8-86a6-89e4aeeebe16 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AXIS Image Management System |
| Version Model Number | Ver 5 |
| Catalog Number | Axis |
| Company DUNS | 107037079 |
| Company Name | SONOMED, 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 | 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 |
| 00896100002002 - AXIS Image Management System | 2022-03-29Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud. |
| 00896100002002 - AXIS Image Management System | 2022-03-29 Software application for ophthalmic image management system with a browser-based interface for image review and analysis of opht |
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