Search Results
Found 1 results
510(k) Data Aggregation
K Number
K213782Device Name
Single-Use Video Bronchoscopes, Digital Controller
Manufacturer
Micro-Tech (Nanjing) Co., Lts
Date Cleared
2022-07-08
(217 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Micro-Tech (Nanjing) Co., Lts
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single-Use Video Bronchoscopes have been designed to be used with the Digital Controller, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Single-Use Video Bronchoscope is only designed for use in hospitals.
The Single-Use Video Bronchoscope is a disposable medical device for use on adults.
The Digital Controller can be used in conjunction with Micro-Tech scope products to provide illumination brightness adjustment ability and receive, process and output images from them for endoscopy.
Device Description
The Video Bronchoscope System consists of:
Single-Use Video Bronchoscope:
- SVB11001
- SVB22001
- SVB33001
Digital Controller:
- DC00001
The Single-Use Video Bronchoscopes are all sterile single use flexible bronchoscope and Digital Controller is a reusable device.
The Single-Use Video Bronchoscopes have the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Working channel
- Camera and LED light source at the distal tip.
The light emitted by the LED cold light source of the Single-Use Video Bronchoscopes lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS. The CMOS acquisition image is controlled by the circuit, and the standard color video signal is output to the digital video processor via the encoding circuit. The digital video processor adjusts the brightness of the light source and outputs the standard color video signal. The imaging sensor pixel count is 400× 400 and the pixel size is 1.75 µm × 1.75 µm.
The optical components and their arrangement at the distal tip for all models of Single-Use Video Bronchoscopes are identical.
The Single-Use Video Bronchoscopes have different size as follows:
- Maximum insertion portion width
- Deflection angle
- Minimum instrument channel width
The Digital Controller has the following physical and performance characteristics:
- Displays the image from The Single-Use Video Bronchoscope on the screen
- Can record screenshots or video of image from the Single-Use Video Bronchoscope
- Can connect to an external monitor
- Reusable device
Ask a Question
Page 1 of 1