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510(k) Data Aggregation
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
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
K183494Device Name
R190/R191 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2019-04-05
(109 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
R190/R191 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
R190/R191 LCD Monitor is the display system with the resolution (1280*1024), high luminance (800cd/m2), and can present up to 1.07 billion colors(1024 grayscale), 1 DICOM look up table inside. R190/R191 uses luminance stabilization mechanism to ensure brightness stability in the product service time.
The product is consisted of the following components:
-19inches, Mono-TFT LCD Panel
- M150M/P38 motherboard/FR-4
- R190/R191 LCD Monitor software
- Power cable
- Data Cable.
The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards.
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K Number
K183492Device Name
JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2019-03-13
(86 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-C620G LCD/JUSHA-C620/C620G/C620 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-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor is the display system with the high resolution (3280*2048), high luminance (500 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C620G 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-C620G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction, focusview and text mode 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:
- 30" Color TFT LCD Panel
- C44&C62 Mother board/FR-6/V1.2
- JUSHA-C620G 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:
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
K183498Device Name
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2019-02-05
(50 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-C270G/JUSHA-C270/C270G/C270 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-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (600 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C270G 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 - DMX0302CR0/main board/V1.2 - JUSHA-C270G LCD Monitor software - Power Adapter - Data Cable.
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K Number
K183497Device Name
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
Manufacturer
Nanjing Jusha Display Technology Co., Ltd.
Date Cleared
2019-01-15
(29 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-M260G/JUSHA-M260/M260G/M260 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-M260G/JUSHA-M260/M260G/M260 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (800 cd/m²), and 14-bit grayscale (16384 level), built-in DICOM standard LUT. In particular, JUSHA-M260G has real-time DICOM automatic calibration 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
- DMX0302CR0/main board/V1.2
- JUSHA-M260G LCD Monitor software
- Power Adapter
- Data Cable.
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