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510(k) Data Aggregation
K Number
K233119Device Name
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2024-12-28
(458 days)
Product Code
PZZ
Regulation Number
864.3700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device. They are an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Device Description
The C811WT. PA27T. C811W. PA27 are 8MP Color LCD Displays, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners that have been validated for use with the display.
The displays are equipped with a 27-inch color LCD panel with a fine pixel pitch. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging.
For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen.
C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen.
The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.
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K Number
K233897Device Name
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2024-02-06
(57 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C510S, G510S, CB5MP, MB5MP, C516S and G516S are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Device Description
5MP LCD Monitors C510S, G510S, CB5MP, MB5MP, C516S, G516S are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2560 x 2048. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable and the calibration is continuous, so these products meet the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
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K Number
K202374Device Name
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2020-10-19
(61 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These products are intended to be used in displaying digital images for review and analysis by trained medical practitioners. They do not support the display of mammography images for diagnosis.
Device Description
C44W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for Ultrasound and General Radiography. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control. 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for erqonomic comfort.
C82W+ is a 31.5-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
C83W+ and C85W+ are 27-inch TFT color LCD monitors. They are specifically designed to provide the high definition images output for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3840 x 2160. With built-in brightness stabilization control circuit, make sure the brightness of this monitors are stable in their life, and the products meet the demand of high precision medical imaging.
For C44W+, C82W+, C83W+, C85W+, the only difference is the screen. C83W+ and C85W+ have the same screen, but their customers are different, which results in the two models.
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K Number
K201211Device Name
3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2020-09-03
(121 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography.
The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.
Device Description
3MP Color LCD monitors C32S+, C32SP+; 3MP Monochrome LCD monitors G32S+, G32SP+ are specifically designed to provide the high definition image outputs for general Radiography.
The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panels, supporting resolution 2048 x 1536. The built-in brightness stabilization control circuits make sure the brightness of these monitors are stable in their life and the calibrations are continuous, so the products meet the demands of high precision medical imaging. For the C32SP+ and G32SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.
Model variations are distinguished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C32S+ is a color LCD monitor; G32SP+ is a monochrome LCD monitor with the additional glass screen.
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K Number
K201599Device Name
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2020-07-02
(20 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2MP Color/Monochrome LCD Monitors C22S+, C22SP+, G23S+, G23S+, G23SP+ are intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. The monitors do not support the display of mammography images for diagnosis.
Device Description
C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ are 21.3-inch TFT LCD color/ grayscale monitors. They are specifically designed to provide the high definition image outputs for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 1200 x 1600. The built-in brightness stabilization control circuits make sure the brightness of these monitors is stable in their life and the calibration is continuous, so the products meet the demand of high precision medical imaging. For C22SP+, G23SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen.
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K Number
K200864Device Name
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2020-05-19
(48 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 5MP Color LCD Monitors C53S+, C53SP+ and 5MP Monochrome LCD Monitors G53S+, G53SP+ are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. They're intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Device Description
5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ are 21.3-inch TFT LCD monitors, which are specifically designed to provide the high definition image output for general radiography. These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 2048 x 2560. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable in their lives and the calibration is continuous, so these products meet the demand of high precision medical imaging. For C53SP+ and G53SP+ surface protection panels with anti-reflection coating, there are characteristics such as anti-reflection, easy cleaning and anti-scratch screen. Model variations are distinquished by characters. C means the Color monitor, G means the Monochrome monitor, and P means the monitor with an additional glass screen. For example, C53S+ is a color LCD monitor; G53SP+ is a monochrome LCD monitor with the additional glass screen.
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K Number
K182291Device Name
6MP Color LCD Monitor (C61W+)
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2018-11-20
(89 days)
Product Code
PGY, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 6MP Color LCD Monitor (C61W+) is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Device Description
C61W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for general radiography. With built-in multi-display modes, the monitor facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, the monitor ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
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K Number
K172815Device Name
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2017-10-27
(39 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Device Description
Beacon LCD monitor (G22S+, G22SP+, C22S+, C22SP+) is for viewing medical images other than those of mamography. Its using the latest generation of LED back light panel, with the resolution 1600 x 1200 (landscape), 1200 x 1600 (portrait), built-in brightness stabilization circuit, the monitor can guarantee the stable brightness and persistent calibration throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, making the image and display clearer. The monitor supports DVI-D, DP and VGA.
Model variations are distinguished by characters. G means the Monochrome monitor, C means the Color monitor, and P means the monitor with an additional glass screen. For example, G22S+ is a monochrome LCD monitor; C22SP+ is a color LCD monitor with the additional glass screen.
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K Number
K162527Device Name
8MP Color LCD Monitor (C81W+)
Manufacturer
Shenzhen Beacon Display Technology Co., Ltd.
Date Cleared
2016-09-30
(21 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Beacon Display Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Device Description
The C81W+ is an 8MP color LCD monitor for viewing medical images including breast tomosynthesis, digital mammography, ultrasound and general radiography. Its using the latest generation of LED back light panel, with high resolution 4096X2160, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
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