(63 days)
Not Found
No
The description focuses on display technology features like resolution, luminance, color depth, and calibration standards (DICOM, GAMMA). There is no mention of AI/ML algorithms for image analysis, processing, or decision support. The "ambient brightness adaptation," "real-time DICOM automatic calibration," "full-screen brightness equalization," and "presence induction system" are described as automatic adjustments based on environmental factors and standards, not learned patterns or complex data analysis characteristic of AI/ML.
No
The device is described as an LCD monitor intended for displaying medical images for diagnosis, and its function is to provide accurate visual representation of these images. It does not provide any form of treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used in displaying digital images for diagnosis of X-ray or MRL, et. by trained medical practitioners." This indicates its role in the diagnostic process.
No
The device description explicitly lists hardware components such as an LCD panel, main board, power adapter, and data cable, in addition to software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: IVDs are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Intended Use: The intended use of the JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is to display digital images from X-ray or MRI for diagnosis. This involves displaying images generated by other medical devices, not performing tests on biological samples.
- Device Description: The device description focuses on the technical specifications of the monitor for image display (resolution, luminance, color, DICOM support, etc.). It does not mention any components or functionalities related to handling or analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Mention of biological samples.
- Description of reagents or assays.
- Performance metrics related to analytical or clinical performance on biological samples (sensitivity, specificity, etc.).
The device is clearly intended for displaying medical images for diagnostic purposes, which falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for 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.
Product codes
PGY
Device Description
JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the display system with the high resolution (3280x2048), 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to demonstrate the JUSHA-C630G meets all performance standards as follows: - . Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions - Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline. - Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline. - Measurement of small-spot contrast ratio. ● - Measurement of temporal response - . Performance data on luminance stability
Electrical safety and EMC testing were conducted on the JUSHA-C630G The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
JUSHA-C620G; K183492
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nanjing Jusha Display Technology Co., Ltd. Donny Lee Certification Engineer 8A, Block 1, 301 Hanzhongmen Street Nanjing, Jiangsu 210036 China
September 19, 2022
Re: K222121
Trade/Device Name: C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: July 18, 2022 Received: July 18, 2022
Dear Donny Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K222121
Device Name C630G/JUSHA-C630G/C630/JUSHA-C630 LCD Monitor
Indications for Use (Describe)
IUSHA-C630G/USHA-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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | July 12, 2022 | |
|---|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd | |
| Add: 8A, Block 1. Nanjing International Service Outsourcing Mansion, | ||
| No. 301, Hanzhongmen street, Nanjing City, Jiangsu Province, 210036 | ||
| China. | ||
| Contact Person: | Donny Lee | |
| Certification Engineer | ||
| Nanjing Jusha Display Technology Co., Ltd | ||
| Tel: +86-25- 83305050 | ||
| Fax: +86-25- 58783273 | ||
| Device Trade Name: | JUSHA-C630G LCD Monitor, JUSHA-C630 LCD Monitor, | |
| C630G LCD Monitor, C630 LCD Monitor | ||
| Common/Usual Name: | 6MP Color LCD Monitor | |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 | |
| Product Code: | PGY | |
| Predicate Device(s): | JUSHA-C620G; K183492 | |
| 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. | |
| Intended Use: | JUSHA-C630G/JUSHA-C630/C630G/C630 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. | |
| Technology: | JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the
display system with the high resolution $(3280\times2048)$ , 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. | |
| Determination of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The LCD Monitor complies with voluntary standards as following:
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.
JUSHA-C630G/ JUSHA-C630/ C630G/ C630 LCD Monitor is
substantially equivalent to JUSHA-C620G. Comparison table of the
principal characteristics of two devices is shown in the Attachment 1 | |
| | 1. Attachment 1
The following quality assurance measures were applied to the development of the system:
Risk Analysis Requirements Reviews Design Reviews Raw materials verification Testing on unit level (Module verification) Integration testing (System verification) Final acceptance testing (Validation) Performance testing (Verification) Safety testing (Verification) Summary of Clinical Tests:
The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence.
The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness. | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd considers C630G LCD Monitor to be safe and effective, and its performance is substantially equivalent to the predicate device(s). | |
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12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed JUSHA-C630G LCD Monitor device to the legally marketed predicate JUSHA-C620G LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-
C630/C630G/C630 LCD
Monitor | |
| 510(k) Number | K183492 | K222121 | |
| Screen
technology | 30" Color TFT LCD Panel | 30" Color TFT LCD Panel | Same |
| Viewing angle
(H, V) | Horizontal 170°, Vertical
170° | Horizontal 170°, Vertical
170° | Same |
| Resolution | 3280 x 2048 | 3280 x 2048 | Same |
| Display area | 645.5 (H) x403.0 (V) mm | 645.5(H)×403.0(V)mm | Same |
| Contrast Ratio | 1000:1 | 1000:1 | Same |
| Recommended
Luminance | 500cd/m² | 500cd/m² | Same |
| Pixel Pitch | 0.197x0.197 mm | 0.197×0.197mm | Same |
| Backlight | LED | LED | Same |
| Display Colors | 16-bit, 281.47 trillion colors | 16-bit, 281.47 trillion colors | Same |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | Same |
| Video Signal Output | | | |
| Output signals | DisplayPort x 1 | DisplayPort x 1 | Same |
| Display
controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | | | |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| | | | |
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-
C630/C630G/C630 LCD
Monitor | |
| 510(k) Number | K183492 | K222121 | |
| Power
Requirement | AC 100240V 5060Hz | 24V DC | The differences
caused by
components used
in the LCD
Monitor. This
only shows the
power
requirement is
different, not
raising different
questions of its
safety and
effectiveness. |
| Power
Consumption/Sa
ve Mode | 150W/less than 0.5W | 150W/less than 0.5W | Same |
| Power
Management | DVI DMPM | DVI DMPM | Same |
| | DisplayPort 1.1a | DisplayPort 1.2 | |
| Miscellaneous Features/Specifications | | | |
| USB
Ports/standard | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | Same |
| Dimensions w/o | Without stand: | Without stand: | Different |
| stand | | | housing design |
| (W x H x D) | 721.5mm×493.5mm×
110mm | 705mm×477mm×77mm
With stand: | which has
nothing to do
with the display |
| | With stand:
721.5mm×585mm×
262mm | 705mm×567mm×262mm | function. |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-
C630/C630G/C630 LCD
Monitor | |
| 510(k) Number | K183492 | K222121 | |
| Indication for
use | JUSHA-C620G 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. | JUSHA-C630G 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. | Same |
| Applicable
standard | 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 | 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 | Same |
7
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PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the JUSHA-C630G meets all performance standards as follows:
- . Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline.
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio. ●
- Measurement of temporal response
- . Performance data on luminance stability
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the JUSHA-C630G The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC. Animal and clinical study
The subject of this premarket submission, JUSHA-C630G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor.
or is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device. The device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-C630G Medical Display does not raise any new issues of safety or effectiveness.