FDA.reportPublic FDA data

4K UHD Camera System

Primary DI
06971381250091
Brand
4K UHD Camera System
Company
Scivita Medical Technology Co., Ltd.
Model
ES-CS4K200/100C
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.
Published
2023-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EOBNasopharyngoscope (Flexible Or Rigid)
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
FGBUreteroscope And Accessories, Flexible/Rigid
GCJLaparoscope, General & Plastic Surgery
HETLaparoscope, Gynecologic (And Accessories)
HRXArthroscope
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2
HRXArthroscopeOrthopedic2
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200216000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2002160004K UHD Camera SystemScivita Medical Technology Co., Ltd.2020-08-21HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971381250091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971381250091069713812500916971381250091

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius28 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
544519831
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971381254228Single-use Flexible UreteroscopeSUV-2C-B2026-07-16
06971381252736Single-use Extraction BasketsEBF-1529CG2024-12-06
06971381252743Single-use Extraction BasketsEBF-1511CG2024-12-06
06971381252750Single-use Extraction BasketsEBF-1511SG2024-12-06
06971381252767Single-use Extraction BasketsEBF-1506SG2024-12-06
06971381252774Single-use Extraction BasketsEBF-1506CG2024-12-06
06971381252781Single-use Extraction BasketsEBF-1507SG2024-12-06
06971381252798Single-use Extraction BasketsEBF-1507CG2024-12-06
06971381252804Single-use Extraction BasketsEBF-1508SG2024-12-06
06971381252811Single-use Extraction BasketsEBF-1508CG2024-12-06
06971381252828Single-use Extraction BasketsEBF-2029SG2024-12-06
06971381252835Single-use Extraction BasketsEBF-2029CG2024-12-06
06971381252903Single-use Extraction BasketsEBF-2006SG2024-12-06
06971381252910Single-use Extraction BasketsEBF-2006CG2024-12-06
06971381252927Single-use Extraction BasketsEBF-2007SG2024-12-06
06971381252934Single-use Extraction BasketsEBF-2007CG2024-12-06
06971381252941Single-use Extraction BasketsEBF-2008SG2024-12-06
06971381252958Single-use Extraction BasketsEBF-2008CG2024-12-06
06971381252729Single-use Extraction BasketsEBF-1529SG2024-12-06
06971381253146Single-use Biopsy ForcepsBFUW-1029P-YG2023-12-28

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Primary DI, Brand, Company table
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