| Primary Device ID | 00860009377608 |
| NIH Device Record Key | 3a4100d0-3736-4c71-91e8-67eb9f45a2ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D-Scope Workstation Software |
| Version Model Number | 6 |
| Company DUNS | 607401119 |
| Company Name | D-Scope Systems |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009377608 [Primary] |
| OUG | Medical Device Data System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2023-10-25 |
| 00860009377608 - D-Scope Workstation Software | 2023-11-02D-Scope Systems workstation software is a hardware-agnostic application for HD-quality medical video and image recording in clinical and OR settings. The user interface allows capture, marking, storage and sharing of files that has integration capability with patient EMR (HL7) and PACS/VNA (DICOM). The application and its browser allow access to a secure space within the client's network that facilitates remote and local file review, referrals and consultations with a HIPAA conformant logon authorization. Intended functions include medical process automation: procedural steps, population of patient demographic data, and management of active medical media from scheduling through discharge. |
| 00860009377608 - D-Scope Workstation Software | 2023-11-02 D-Scope Systems workstation software is a hardware-agnostic application for HD-quality medical video and image recording in clin |
| 00860009377615 - D-Scope Server Software | 2023-11-02 D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integr |