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Found 16 results
510(k) Data Aggregation
K Number
K191137Device Name
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
Manufacturer
JVC Kenwood Corporation
Date Cleared
2019-07-02
(64 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC Kenwood Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-S500 and MS-S500 are intended to be used in displaying 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
CL-S500 : 21.3 inch Color LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness and color unevenness by Uniformity Correction Function to achieve the uniformity of luminance and color on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC quideline is conducted
MS-S500 : 21.3 inch Monochrome LCD Monitor 2048 x 2560 (landscape), 2560 x 2048 (portrait)
High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.
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K Number
K182539Device Name
2MP Color LCD Monitor CL-R211
Manufacturer
JVC Kenwood Corporation
Date Cleared
2018-10-03
(19 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC Kenwood Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-R211 (CL-R211xxxxx) is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Device Description
2MP Color LCD Monitor CL-R211. Resolution: 1600 x 1200 (landscape), 1200 x 1600 (portrait). DVI (digital interface) and DisplayPort (digital interface).
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K Number
K173434Device Name
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
Manufacturer
JVC KENWOOD Corporation
Date Cleared
2017-12-14
(42 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CL-S200 (CL-S200xxxxx) and CL-S300 (CL-S300xxxxx) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Device Description
CL-S200 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)
CL-S300 : 2048 x 1536 (landscape), 1536 x 2048 (portrait)
DVI (digital interface) and DisplayPort (digital interface)
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K Number
K161895Device Name
2MP Color LCD Monitor CCL214 (CL21214)
Manufacturer
JVC KENWOOD Corporation
Date Cleared
2016-09-08
(59 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
2MP Color LCD Monitor CCL214 (CL21214) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
Device Description
CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-D (digital interface) and DisplayPort (digital interface).
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K Number
K160326Device Name
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
Manufacturer
JVC KENWOOD Corporation
Date Cleared
2016-02-23
(18 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
5MP Monochrome LCD Monitor MS55i2 (ML21055, MD211G5) and 5MP Color LCD Monitor CCL550i2 (CL21550) are intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. They are to be used in digital mammography PACS, modalities including FFDM, and breast tomosynthensis
Device Description
MS55i2 (ML21055, MD211G5) is a 21.3 inch (54 cm) monochrome LCD monitor and CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor. Their displays' resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
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K Number
K151134Device Name
21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)
Manufacturer
JVC KENWOOD CORPORATION
Date Cleared
2015-05-27
(28 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) is intended to be used in displaying medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
Device Description
CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).
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K Number
K151007Device Name
21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
Manufacturer
JVC KENWOOD CORPORATION
Date Cleared
2015-05-08
(23 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
21.3 inch (54 cm) inch Color Digital Mammography 5M pixel LCD Monitor CCL550i2 (CL21550) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
Device Description
CCL550i2 (CL21550) is a 21.3 inch (54 cm) color LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface) and DisplayPort.
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K Number
K143076Device Name
20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)
Manufacturer
JVC KENWOOD CORPORATION
Date Cleared
2014-11-12
(16 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
Device Description
ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).
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K Number
K142536Device Name
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
Manufacturer
JVC KENWOOD CORPORATION
Date Cleared
2014-10-03
(24 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
21.5 inch (54.5 cm) Color 2M pixel LCD Monitor CCL220 (CL2220) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
Device Description
CCL220 (CL22220) is a 21.5-inch (54.5 cm) Color LCD monitor whose display resolution is 1920 x 1080 (landscape), 1080 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
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K Number
K142540Device Name
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
Manufacturer
JVC KENWOOD CORPORATION
Date Cleared
2014-10-03
(24 days)
Product Code
PGY
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JVC KENWOOD CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
24.1 inch (61.1 cm) Color 2M pixel LCD Monitor CCL244 (CL24244) is intended to be used in displaying and viewing medical images from PACS, endoscope and ultrasonograph for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.
Device Description
CCL244 (CL24244) is a 24.1-inch (61.1 cm) Color LCD monitor whose display resolution is 1920 x 1200 (landscape), 1200 x 1920 (portrait) supporting multiple interfaces such as HDMI, BNC, S-video and HD-SDI in addition to DVI and D-Sub.
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