4k UHD Camera System
The 4K UHD Camera System provides images of the operative area during endoscopic surgery. Model ES-CS4K100/100C combines an ES-CS4K100 camera control unit with an ES-CS4K100C camera head.…
The 4K UHD Camera System provides images of the operative area during endoscopic surgery. Model ES-CS4K100/100C combines an ES-CS4K100 camera control unit with an ES-CS4K100C camera head. Doctors and trained healthcare professionals use it in hospitals, clinics and medical offices with compatible endoscopic equipment.
An objective lens connects the camera head to the endoscope. CMOS sensors convert the optical image into electrical signals for processing and video output. The control unit sends images through HDMI or SDI connections to a monitor, supporting 4K and 2K output.
Listed Item
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.
Supporting Equipment
The system requires a compatible endoscope, separate light source and monitor. It is reusable and supplied nonsterile; the camera head requires cleaning and disinfection after each use. Images and video can be recorded to an external USB device.
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Scivita Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Manufacturer |
| 510(k) | K200216 |
| Record published | 2023-05-17 |
| Record revised | 2025-06-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature 5 to 28 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 20 to 90 % RH; Storage environment temperature -40 to 55 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ES-CS4K100/100C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoplus | Endoplus | 448 |
| Integra® MicroFrance® | Integra Microfrance SAS | 273 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 139 |
| Laparoscope, Gynecologic (And Accessories) | Karl Storz GmbH & Co. KG | 119 |
| Elmed | Elmed, Inc. | 96 |
| Olympus | Olympus Winter & IBE Gmbh | 71 |
| Core Dynamics | ConMed Corporation | 52 |
| Symmetry | Aspen Surgical Products, Inc. | 48 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 45 |
| Laparoscope, Gynecologic (And Accessories) | Richard Wolf Gmbh | 37 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Blueendo | Trokamed Gmbh | 28 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200216 | 2020-08-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.