4K UHD Camera System

Basic Information

• Brand Name: 4K UHD Camera System
• Primary DI: 06971381250091
• Version / Model: ES-CS4K200/100C
• Company Name: Scivita Medical Technology Co., Ltd.
• Labeler DUNS: 544519831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-17
• Public Version: 5
• Public Version Date: 2025-06-26
• Public Version Status: Update
• Public Device Record Key: dbea6e8a-250c-4304-a50f-0890fe684109

Device Description

The product is composed of a 4K camera control unit, a 4K camera head, objective lens, a power cable, and video cables. Video cables contains: HD-SDI cable, HDMI cable. HD-SDI cable, HDMI cable and objective lens are optional. 4K UHD Camera System is mainly used to provide imaging of the operative area in endoscopic surgery. Do not use this system for any other purpose.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
HRX	Arthroscope	Orthopedic	888.1100	2
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	876.1500	2
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4760	2
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18034	Endoscopic video image processing unit	An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971381250091	GS1

Premarket Submissions

Submission Number	Supplement Number
K200216	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 28 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 55 Degrees Celsius