Identity
- Trade Name
- D-Scope Workstation Software FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- D-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. FDA UDI
- Model / Reference
- 6 FDA UDI
- Description
- D-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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009377608 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscopic video image processing unit
D-Scope Workstation Software by D-Scope Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image processing unit.
- Pixa — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
- ILO — ILO electronic GmbH · Class I
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- VIDEO PROCESSOR — PENTAX of America, Inc. · Class II
- Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd · Class II
- ILO — ILO electronic GmbH · Class I
- 3NT Video Console — 3nt Medical , Ltd. · Class II
- HDMI cable — MacroLux Medical Technology Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- D-Scope Systems
Sources (1)
- FDA UDI 3a4100d0-3736-4c71-91e8-67eb9f45a2ba 33 fields · synced Jun 1, 2026