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510(k) Data Aggregation
K Number
K243429Device Name
HJY VisualNext 3D Endoscopic Vision System
Manufacturer
HJY Smart Medical Device Co., Ltd.
Date Cleared
2025-05-21
(197 days)
Product Code
GWG
Regulation Number
882.1480Why did this record match?
Applicant Name (Manufacturer) :
HJY Smart Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is a self-help tool for individuals aged 18 or older with diagnosed depression. It is intended to be used in addition to usual care and not as a replacement for it.
Device Description
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K Number
K222735Device Name
HJY VisualNext Endoscopic Vision System
Manufacturer
HJY Smart Medical Device Co., Ltd.
Date Cleared
2023-07-28
(322 days)
Product Code
GWG
Regulation Number
882.1480Why did this record match?
Applicant Name (Manufacturer) :
HJY Smart Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HJY VisualNext™ Endoscopic Vision System is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of structures within the brain during neurological surgical procedures as well as for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy.
Device Description
The HJY VisualNext™ Endoscopic Vision System is a system used for viewing internal surgical sites during surgical procedures. The system consists of the following components:
- . Endoscope Control Unit (ECU) (Model number: HDSES01)
- . Endoscope (Model number: HDSE201)
The endoscope is physically connected via a 5m BNC cable to the Endoscope Control Unit (ECU). The Endoscope consists of 2 LED lamps and a CMOS camera, embedded in the proximal end of a rigid metal arthroscope, which captures the image and transmits to and is processed by the Endoscope Control Unit (ECU), subsequently output to and presented on an external monitor. Images are recordable and markable for further analysis. The Endoscope Control Unit (ECU) is not connectable to intranet or Internet.
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