(43 days)
Not Found
No
The description focuses on the display technology and its features for image viewing, not on AI/ML-driven analysis or processing of the images themselves. The "automatic adjustment" features described appear to be based on ambient conditions and calibration, not complex AI/ML algorithms for image interpretation.
No.
Explanation: The device is an LCD monitor intended for displaying and viewing digital mammography images for review and diagnosis, not for providing therapy.
No
Explanation: The device is a display monitor used for viewing digital images for review and diagnosis, not a diagnostic device itself that processes or analyzes data to produce a diagnosis.
No
The device description explicitly lists hardware components such as an LCD panel, main board, power adapter, and data cable. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The JUSHA-M550G/JUSHA-M550/M550 LCD Monitor is a display system. Its intended use is to display and view digital images (specifically mammography) for review and diagnosis. It does not perform any tests on biological samples.
- Intended Use/Indications for Use: The description clearly states its purpose is for "displaying and viewing digital images...for review, and diagnosis." This is a function related to medical imaging, not in vitro testing.
- Device Description: The components listed are those of a display monitor (LCD panel, main board, software, power adapter, data cable). There are no components related to sample handling, analysis, or reagent use, which are typical of IVD devices.
- Mentions image processing: While it mentions image processing, this refers to the processing of the digital images for display, not the processing of biological samples.
- Input Imaging Modality: The input is "digital images," not biological samples.
- Performance Studies: The performance studies described focus on the display's characteristics (luminance, uniformity, contrast, temporal response, stability) and electrical safety/EMC. These are relevant to a medical display, not an IVD device.
In summary, the JUSHA-M550G/JUSHA-M550/M550 LCD Monitor is a medical imaging display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
PGY
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images, including standard and multi-frame digital mammography.
Anatomical Site
Breast
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
Bench testing was conducted to demonstrate the JUSHA-M550G meets all performance standards. Tests included: 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 TGI18 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 also conducted, and the device complies with IEC 60601-1 for safety and IEC 60601-1-2 for EMC. No animal or clinical studies were required.
Key Metrics
Not Found
Predicate Device(s)
BARCO MDMG-5221; K161229
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Nanjing Jusha Display Technology Co., Ltd % Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, Jiangsu 210036 CHINA
Re: K190848
Trade/Device Name: JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: Class II Product Code: PGY Dated: April 10, 2019 Received: April 10, 2019
Dear Zilong Liang:
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.
May 14, 2019
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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190848
Device Name
JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor
Indications for Use (Describe)
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.
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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3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | February 26, 2019 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 301, 8F Block A, No.1, Nanjing International Service | |
| Outsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China | |
| Contact Person: | Zilong Liang |
| Certification Manager | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25- 58783273 | |
| Device Trade Name: | JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor |
| Common/Usual Name: | 5MP Color LCD Monitor |
| Classification Name: | System, image processing, Radiological 21CFR 892.2050 |
| PGY | |
| Product Code: | |
| Predicate Device(s): | BARCO MDMG-5221; K161229 |
| 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 |
| 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-M550G/JUSHA-M550/M550G/M550 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
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. |
| Technology: | 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 |
| 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 |
| | Requirements and tests |
| | JUSHA-M550G is substantially equivalent to BARCO MDMG-5221.
JUSHA-M550G employs the maximum resolution values same as that
of BARCO MDMG-5221. Comparison table of the principal
characteristics of 2 devices is shown in the Attachment 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 the
JUSHA-M550G LCD Monitor to be as safe, as effective, and
performance is substantially equivalent to the predicate device(s) |
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5
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This comparison identifies the similarities and differences of the proposed JUSHA-M550G LCD Monitor device to the legally marketed predicate BARCO MDMG-5221 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD
Monitor | |
| 510(k) Number | K161229 | / | |
| Display Performance/Specifications | | | |
| Screen
technology | 21.3inches, Mono-TFT LCD
Panel | 21.3inches, Mono-TFT LCD
Panel | Same |
| Viewing angle
(H, V) | Horizontal 176°,Vertical
176° | Horizontal 170°, Vertical
170° | - |
| Resolution | 2560 x 2048/2048x 2560 | 2560 x2048/2048x 2560 | Same |
| Display area | 422.4(H) x 377.9 (V) mm | 422.4(H) x377.92(V) mm | - |
| Contrast Ratio | 950:1 | 1700:1 | - |
| DICOM
calibrated
luminance | 1000cd/m2 | 1000cd/m2 | Same |
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same. |
| DICOM LUT | 10-bit:1024 | 16-bit:65536 | The
JUSHA-M550G
LCD Monitor
uses a color bit
expansion
technology to
improve image
display quality,
the image clarity
is better than the
image displayed
on the predicate
device. |
| Luminance
calibration | Built in calibration sensor
provided | Built in calibration sensor
provided | Same |
| Video Signal Input | | | |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD
Monitor | |
| 510(k) Number | K161229 | / | |
| Input signals | DVI standard 1.0,
DisplayPort 1.2a | DVI standard 1.0,
DisplayPort 1.2a | Same |
| Input
terminational | DVI-D x 1,
DisplayPort x 1 | DVI-D x 1,
DisplayPort x 1 | Same |
| Output signals | - | DisplayPort 1.2a | - |
| Output | - | DisplayPort x 1 | - |
| Terminational | | | |
| Display
controller | Off the shelf | Off the shelf | Same |
| | | Power Related Specification | |
| Power
Requirement | AC 100240V 5060Hz | AC 100240V 5060Hz | Same |
| Power
Consumption/Sa
ve Mode | 57W/less than 0.7W | 55W/less than 0.5W | The differences
caused by
components used
in the LCD
Monitor. This
only shows the
power
consumption is
different,
nothing to do
with the display
function |
| Power
Management | DVI DMPM
DisplayPort 1.2a | DVI DMPM
DisplayPort 1.2a | Same |
| Miscellaneous Features/Specifications | | | |
| USB
Ports/standard | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | 1 upstream (endpoint),
2 downstream/ Rev. 2.0 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Dimensions w/o
stand
(W x H x D) | Without stand:
392mm x484mm x122mm
With stand:
780mm x550mm x261mm | Without stand:
363mm x475mm x66mm
With stand:
363mm x635mm x238mm | Different
housing design
due to the
different panel
size. |
| Indication for
use | BARCO MDMG-5221
device 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
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. | JUSHA-M550G/JUSHA-M5
50/M550G/M550 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 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. | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD
Monitor | |
| 510(k) Number | K161229 | / | |
| Applicable
standard | Electrical Safety test (IEC
60601-1)
EMC test (IEC 60601-1-2) | 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 | Same |
7
8
9
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-M550G 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 TGI18 guideline.
- Measurement of the chromaticity non-uniformity characteristics of the display . screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio. .
10
- 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-M550G 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-M550G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-M550G Medical Display 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-M550G Medical Display does not raise any new issues of safety or effectiveness.