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510(k) Data Aggregation
K Number
K230728Device Name
JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd
Date Cleared
2023-06-09
(85 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C660G/C810G LCD Monitor is intended to be used in displaying digital images diagnosis of X-ray or MRI.etc.by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Device Description
JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the display system with high resolution (3280×2048), high luminance (800 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, C660G has ambient brightness adaptation inside, on top of which C660G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.
The product is consisted of the following components:
- the display with stand
- a graphic card
- agraphic card driver CD
- an AC power cable
- an external power supply
- a Type-C cable
- Three DP cables
- a USB cable
JUSHA-C810G/ C810G LCD Monitor is the display system with high resolution (3840×2160), high luminance (800 cd/m2), and 14-bit grayscale (16384 grayscale), built-in DICOM standard LUT. In particular, C810G has ambient brightness adaptation inside, on top of which C810G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.
The product is consisted of the following components:
- the display with stand
- a graphic card
- agraphic card driver CD
- an AC power cable
- an external power supply
- a DVI cable
- two Mini DP switch to DP cable
- a USB cable
The LCD Monitors are designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
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K Number
K231170Device Name
C350/C350G LCD Monitor; M550/M550G LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2023-06-07
(43 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C350G/C350/JUSHA-C350G/JUSHA-C350 LCD monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
M550G/ M550 /JUSHA-M550G/JUSHA-M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially de 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
C350G LCD Monitor is the display system with the high resolution (2048*1536), high luminance (800 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C350G has ambient brightness adapting, real-time DICOM automatic calibration and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:
- 21.3" Color TFT LCD Panel
- DMX3304AR2/main board
- C350G LCD Monitor software
- a graphic card
- a graphic card driver CD
- a CGA software CD
- an AC power cord
- an external power supply
- a DVI cable
- a DP cable
- a USB cable
M550G LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, M550G has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components:
- 21.3" Mono-TFT LCD Panel
- DMX3304AR2/main board
- M550G LCD Monitor software
- a graphic card
- a graphic card driver CD
- an AC power cord
- an external power supply
- a DVI cable
- a DP cable
- a USB cable
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K Number
K230723Device Name
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd
Date Cleared
2023-05-18
(63 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Device Description
C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:
- 21.3" Color-TFT LCD Panel
- DMX0704AR1/Main Board/REV: 1.2
- C510G LCD Monitor software
- Power Adapter
- Data Cable.
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K Number
K230643Device Name
CP620G LCD monitor, CP620 LCD monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd
Date Cleared
2023-05-01
(54 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CP620G/CP620 LCD Monitor 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
CP620G/CP620 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (500 cd/m2), and 4398 billion colors, built-in DICOM standard LUT. Monitor is portable and light, the 750g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results.(There is no difference between CP620G and CP620 except for labeling as they are marketed in different areas. CP620G is global sales, CP620 is domestic sales .It does not affect their safety or effectiveness in any terms. ) The product is consisted of the following components: - 13.5" Color-TFT LCD Panel - DMS3400AR0/6 layers/214*150mm/1.0mm/REV:1.0 - CP620G LCD Monitor software - Power Adapter - Data Cable. In accordance with the May 11, 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for the CP620G/CP620 LCD Monitor was determined to be Moderate on account of a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. the software doesn't include any functions of image manipulation. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
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K Number
K222121Device Name
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2022-09-19
(63 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JUSHA-C630G/JUSHA-C630G/C630/C630 LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRL, et. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Device Description
JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the display system with the high resolution (3280×2048), high luminance (1050 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT. In addition, C630G has ambient brightness adaptation inside, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results. The product is consisted of the following components: - 30" Color TFT LCD Panel - DMX0704AR0/main board/REV:1.1 - JUSHA-C630G LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
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K Number
K212231Device Name
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2022-03-25
(252 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor 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 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
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the display system with the high resolution (4200x2800), high luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA- C1210G has ambient brightness adapt inside. In particular, JUSHA- C1210G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:
- 31" Color-TFT LCD Panel
- DMF2604AR0/main board/REV1.0
- JUSHA-C1210G LCD Monitor software
- Power Adapter
- Data Cable.
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K Number
K200742Device Name
JUSHA-CP610 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2020-07-24
(123 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JUSHA-CP610 LCD Monitor, CP610 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Device Description
JUSHA-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g weight make it is easy to carry. With these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:
- 13.5" Color TFT LCD Panel
- DMS0600A board/4 layer/233*127mm/1.0mm/REV:1.1
- JUSHA-CP610 LCD Monitor software
- Power Adapter
- Data Cable.
The software that supports the functions of the CP610 is the same as the software used with the predicate JUSHA C61. The level of concern was determined to be Moderate for the JUSHA-CP610 LCD Monitor.
The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
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K Number
K190831Device Name
E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd
Date Cleared
2019-05-31
(60 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The E240AG LCD Monitor is intended to provide 2D color video displays of images from surgical endoscopic/ laparoscopic camera systems and other compatible medical imaging systems. The E240AG is a widescreen, high definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
Device Description
The E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 23.8-inch widescreen LCD display panel and employs full WUXGA high-definition (HID) performance. In addition to digital signals, the E240AG accepts analog signals and converts them to digital signals. The E240AG LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.
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K Number
K190848Device Name
JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd
Date Cleared
2019-05-14
(43 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JUSHA-M550G/JUSHA-M550/M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Device Description
JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M550G has ambient brightness adapt inside. In particular, JUSHA-M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components: - 21.3" Mono-TFT LCD Panel - DMX0704AR0/main board/REV1.1 - JUSHA-M550G LCD Monitor software - Power Adapter - Data Cable
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K Number
K183496Device Name
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd
Date Cleared
2019-04-08
(112 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Nanjing Jusha Display Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Device Description
JUSHA-C350G LCD Monitor , JUSHA-C350 LCD Monitor , C350G LCD Monitor , C350 LCD Monitor is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (800 cd/m²) and 281.47 trillion colors, built-in DICOM standard LUT. JUSHA-C350G LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. In addition, JUSHA-C350G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction and focusview function, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components: - 21.3" Color TFT LCD Panel - DMX0704AR0/main board/REV1.1 - JUSHA-C350G LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
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