Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Full HD Visualization Endoscopic Image Processor EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Full HD Visualization Endoscopic Image Processor EUDAMEDThe product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity. FDA UDI
- Model / Reference
- HDVS-S300C EUDAMEDFDA UDIHDVS-S300A、 HDVS-S300B、 HDVS-S300C、 HDVS-S300D EUDAMED
- Description
- The product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381252415 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125024A8J EUDAMED
- 510(k) Number
- K251338 FDA 510(k)
- FDA Product Code
- FBN FDA 510(k)EOQ FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic video image processing unit FDA UDI
- Models / Variants
- Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G FDA 510(k)FDA UDIEUDAMEDFull HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) FDA 510(k)FDA UDIEUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)874.4680 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Cholangioscope Visualization System is a flexible cholangioscope and accessories designed for direct visualization of the biliary and pancreatic ducts. It combines a single-use video cholangioscope with a Full HD endoscopic image processor to enable high-resolution imaging for diagnostic and therapeutic procedures in gastroenterology and urology.
This system is supplied as a single-use device for the video cholangioscope components and reusable for the Full HD image processor. The single-use scopes are intended for sterile use in controlled clinical environments, while the image processor requires appropriate storage and maintenance per manufacturer guidelines. Authorized under FDA 510(k) and MDR, the system adheres to regulatory standards for cholangioscopes and endoscopic accessories, classified under device class 2.
Frequently asked questions
What is the primary purpose of the Cholangioscope Visualization System, and which medical specialties benefit from it?
The Cholangioscope Visualization System is designed for direct visualization of the biliary and pancreatic ducts, enabling high-resolution imaging during diagnostic and therapeutic procedures. It is primarily used in gastroenterology and urology, as indicated by its advisory committee classification (GU) and regulatory submissions. This system helps clinicians examine and treat conditions related to these ducts with enhanced clarity.
Are the video cholangioscopes in this system single-use or reusable, and how does this affect their use in clinical settings?
The video cholangioscopes (SCV-P-01G and SCV-P-02G) in this system are single-use devices, intended for sterile use in controlled clinical environments. This design reduces the risk of cross-contamination between patients and ensures compliance with infection control protocols, making them ideal for repeated procedures without reprocessing.
What components of the Cholangioscope Visualization System are reusable, and what maintenance guidelines should be followed?
The Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) is the reusable component of the system. Proper storage and maintenance are required to ensure optimal performance, as outlined in the manufacturer’s guidelines. This includes regular cleaning, calibration, and adherence to environmental conditions to prevent degradation.
How does the system achieve high-resolution imaging, and what models are available for the video cholangioscope?
The system combines a single-use video cholangioscope with a Full HD endoscopic image processor, enabling high-resolution imaging for detailed visualization of the biliary and pancreatic ducts. Two models of the video cholangioscope are available: SCV-P-01G and SCV-P-02G, each designed for specific procedural needs while maintaining the same high-definition output.
What regulatory pathways has the Cholangioscope Visualization System undergone, and how does this affect its market authorization?
The system has been authorized through FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming its adherence to regulatory standards for cholangioscopes and endoscopic accessories. These pathways ensure the device meets safety, performance, and effectiveness requirements for use in clinical settings, particularly in gastroenterology and urology.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251338 | Class II | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
Sources (3)
- FDA 510(k) K251338 24 fields · synced Sep 18, 2026
- FDA UDI 118068d7-a651-4d60-9362-615a7819f605 34 fields · synced May 30, 2026
- EUDAMED 79f30f44-88fb-4246-a27c-65a0b324867a 61 fields · synced Jul 22, 2026