(43 days)
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.
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
The provided text is a 510(k) summary for the Nanjing Jusha Display Technology Co., Ltd. C350/C350G LCD Monitor and M550/M550G LCD Monitor. This document states that no clinical studies were required or conducted to support substantial equivalence for these medical display monitors. Therefore, there is no information available in the provided text regarding acceptance criteria related to a study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment, or clinical performance compared to human readers.
The performance data described are related to bench testing and electrical safety/EMC, which are non-clinical evaluations of the device's technical specifications.
Here's an analysis of what is provided:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of specifications between the proposed devices (C350G and M550G LCD Monitors) and their respective predicate devices (C270G and BARCO MDMG-5221 LCD Monitors). While these are technical specifications, they implicitly represent the performance and quality standards the proposed devices must meet or exceed to be considered substantially equivalent. There isn't a formal "acceptance criteria" table in the sense of a clinical study, but rather a comparison of technical attributes.
Implicit Acceptance Criteria (Technical Specifications) and Reported Device Performance:
- For C350G LCD Monitor (compared to predicate C270G LCD Monitor):
| Attribute | Predicate Device (C270G) Performance | Proposed Device (C350G) Performance | Implicit Acceptance Criteria / Comparison |
|---|---|---|---|
| Screen Technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing angle (H, V) | Horizontal 178°, Vertical 178° | Horizontal 178°, Vertical 178° | Same |
| Resolution | 1600 x 1200 / 1200 x 1600 | 2048 x 1536 | Higher resolution (better) |
| Contrast Ratio | 1400:1 | 1500:1 | Higher contrast (better) |
| DICOM calibrated luminance | 350 cd/m² | Max: 800 cd/m², Recommend: 500 cd/m² | Higher calibrated luminance (better) |
| Pixel Pitch | 0.27x0.27 mm | 0.2115x0.2115 mm | Smaller pixel pitch (better) |
| Backlight | LED | LED | Same |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | Same |
| Luminance calibration | Built-in calibration sensor provided | Built-in calibration sensor provided | Same |
| Video Signal Input | 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 |
| Power Requirement | DC 24V | DC 24V | Same |
| Power Management | DVI DMPM, Display Port 1.1a | DVI DMPM, Display Port 1.2a | Same |
| USB Ports/standard | 1 upstream, 2 downstream / Rev. 2.0 | 1 upstream, 2 downstream / Rev. 2.0 | Same |
| Indication for use | For X-ray or MRI diagnosis; not for digital mammography | For X-ray or MRI diagnosis; not for digital mammography system | Same |
| Applicable standard compliance | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Same |
- For M550G LCD Monitor (compared to predicate BARCO MDMG-5221 LCD Monitor):
| Attribute | Predicate Device (BARCO MDMG-5221) Performance | Proposed Device (M550G) Performance | Implicit Acceptance Criteria / Comparison |
|---|---|---|---|
| Screen Technology | 21.3inches, Mono-TFT LCD Panel | 21.3inches, Mono-TFT LCD Panel | Same |
| Resolution | 2560 x 2048 / 2048 x 2560 | 2560 x 2048 / 2048 x 2560 | Same |
| Contrast Ratio | 950:1 | 2000:1 | Higher contrast (better) |
| DICOM calibrated luminance | 1000 cd/m² | Max: 1000 cd/m², Recommended: 500 cd/m² | Same (meets required luminance) |
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same |
| DICOM LUT | 10-bit:1024 | 16-bit:65536 | Higher bit depth (better) |
| Luminance calibration | Built-in calibration sensor provided | Built-in calibration sensor provided | Same |
| Video Signal Input | 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 |
| Power Management | DVI DMPM, DisplayPort 1.2a | DVI DMPM, DisplayPort 1.2a | Same |
| USB Ports/standard | 1 upstream, 2 downstream / Rev. 2.0 | 1 upstream, 2 downstream / Rev. 2.0 | Same |
| Indication for use | For standard and multi-frame digital mammography, breast tomosynthesis | For standard and multi-frame digital mammography, breast tomosynthesis | Same |
| Applicable standard compliance | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Same |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. The submission states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." Therefore, no clinical test set was used. The "test set" in this context refers to the specific physical units of the monitors that underwent bench testing and electrical safety/EMC testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As no clinical studies were performed, no ground truth established by experts was required for the purpose of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a display monitor, not an AI-powered diagnostic tool. The submission explicitly states "The software doesn't include any functions of image manipulation."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical ground truth was established or used for the purpose of this submission. The "ground truth" for the bench testing would be the physical and electrical specifications of the monitors, measured against industry standards (e.g., TG18 guideline for display characteristics) and engineering requirements.
8. The sample size for the training set
- Not applicable. No machine learning model or "training set" in that sense was used or discussed in this 510(k) summary.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an algorithm was used.
Summary of Study:
The "study" cited in this 510(k) summary to prove the device meets acceptance criteria consists of non-clinical bench testing and electrical safety and electromagnetic compatibility (EMC) testing. This is typical for medical devices that are primarily hardware components and do not have algorithmic diagnostic or therapeutic functions.
- Bench Testing: Evaluated display characteristics such as luminance response, luminance non-uniformity, chromaticity non-uniformity, small-spot contrast ratio, temporal response, and luminance stability. These tests were conducted against general performance standards and guidelines (e.g., TGI18 guideline).
- Electrical safety and EMC testing: The devices demonstrated compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards.
The conclusion is that the proposed monitors are "substantially equivalent" to predicate devices based on these non-clinical tests, implying they are as safe and effective and perform as intended.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nanjing Jusha Display Technology Co., Ltd. % Donny Lee Certification Engineer 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301, Hanzhongmen street Naniing, Jiangsu 210036 CHINA
June 7, 2023
Re: K231170
Trade/Device Name: C350/C350G LCD Monitor: M550/M550G LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: April 25, 2023 Received: April 25, 2023
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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
Jessica Lamb, PhD. 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) K231170
Device Name C350/C350G LCD Monitor M550/M550G LCD Monitor
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(K231170)
1. In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Apr 16, 2023 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 8A, Block 1. Nanjing International Service OutsourcingMansion, No. 301, Hanzhongmen street, Nanjing City, JiangsuProvince, 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: | C350G LCD Monitor, C350 LCD Monitor, JUSHA-C350G LCDMonitor, JUSHA-C350 LCD Monitor (There is no difference betweenC350G LCD Monitor, C350 LCD Monitor, JUSHA-C350G LCDMonitor and JUSHA-C350 LCD Monitor except for labeling as theyare marketed in different areas. It does not affect their safety oreffectiveness in any terms. )M550G LCD Monitor, M550 LCD Monitor, JUSHA-M550G LCDMonitor, JUSHA-M550 LCD Monitor (There is no differencebetween M550G LCD Monitor, M550 LCD Monitor, JUSHA-M550GLCD Monitor and JUSHA-M550 LCD Monitor except for labeling asthey are marketed in different areas. It does not affect their safety oreffectiveness in any terms. ) |
| Common/Usual Name: | 3MP LCD Monitor and 5MP LCD Monitor |
| Classification Name: | Medical Image Management and Processing System, 21 CFR892.2050 |
| Product Code: | PGY |
| Device Class: | Class II |
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| Predicate Device(s): | C270G;K183498BARCO MDMG-5221; K161229 |
|---|---|
| Classification Name: | Medical Image Management and Processing System, 21 CFR892.2050 |
| Product Code: | PGY |
| Device Class: | Class II |
| Device Description: | C350G LCD Monitor is the display system with the high resolution(20481536), high luminance (800 cd/m2), and 281.47 trillion colors,built-in DICOM standard LUT. In particular, C350G has ambientbrightness adapting, real-time DICOM automatic calibration andpresence induction system, with these this display can automaticadjustment according to different requirements in order to achieve thebest 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 cableM550G LCD Monitor is the display system with the high resolution(25602048), high luminance (1000 cd/m2), and 16-bit grayscale(65536 level), built-in DICOM standard LUT. In particular, M550G |
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has ambient brightness adapt inside. In particular, M550G has ambient brightness adapting, real-time DICOM automatic calibration, fullscreen 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 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 C350G and M550G 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 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.
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| 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic disturbances -Requirements and tests. | |
|---|---|
| Intended Use: | C350G/C350/JUSHA-C350G/JUSHA-C350 LCD monitor is intendedto be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is notspecified for digital mammography system.M550G/M550/JUSHA-M550G/JUSHA-M550 LCD Monitor isintended to be used in displaying and viewing digital images, includingstandard and multi-frame digital mammography, for review, analysis,and diagnosis by trained medical practitioners. It is specially dedisplaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis bytrained medical practitioners. It is specially designed for breasttomosynthesis applications. |
| Technology: | C350G LCD Monitor is the display system with the high resolution(20481536), high luminance (800 cd/m2), and 281.47 trillion colors,built-in DICOM standard LUT. In particular, C350G LCD Monitor hasambient brightness adapting, real-time DICOM automatic calibrationand presence induction system, with these this display can automaticadjustment according to different requirements in order to achieve thebest results.M550G LCD Monitor is the display system with the high resolution(25602048), high luminance (1000 cd/m2), and 16-bit grayscale(65536 level), built-in DICOM standard LUT. In particular,M550G/M550 LCD Monitor has ambient brightness adapt inside. Inparticular, M550G LCD Monitor has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalizationand presence induction system, with these this display can automaticadjustment according to different requirements in order to achieve thebest results. |
| Determination of SubstantialEquivalence: | 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 C22.2NO.60601-1:14, Medical equipment medical electrical equipment- Part 1: General requirements for basic safety and essentialperformance |
| 2 | IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medicalelectrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and testsC350G LCD Monitor is substantially equivalent to C270G. M550GLCD Monitor is substantially equivalent to BARCO MDMG-5221.They have equivalent characteristics and functions according tocomparison table, please refer to 2. Product ComparisonThe following quality assurance measures were applied to thedevelopment 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 notrequire clinical studies to support substantial equivalence.The proposed devices are Substantially Equivalent (SE) to thepredicate devices which is US legally market device. Therefore, thesubject devices are determined as safe and effectiveness. |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the C350GLCD Monitor and M550G LCD Monitor to be as safe, as effective,and performance are substantially equivalent to the predicatedevice(s). |
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2. Product Comparison
2. 1 C350G and its predicate device comparison
This comparison identifies the similarities and differences of the proposed C350G LCD monitor device to the legally marketed predicate C270G LCD Monitor device to which substantial equivalency is claimed.
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Display Performance/Specifications | |||
| Screentechnology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing angle(H, V) | Horizontal 178°, Vertical178° | Horizontal 178°, Vertical178° | Same |
| Resolution | 1600 x 1200/1200 x 1600 | 2048x 1536 | C350G has ahigher resolutionthan C270GImage quality isbetter than theimage displayedon the predicatedevice. |
| Display area | 432.0 (H) x 324.0(V) mm | 433.15(H) x324.86(V) mm | - |
| Contrast Ratio | 1400:1 | 1500:1 | C350G has ahigher contrastratio than C270GImage quality isbetter than theimage displayedon the predicatedevice. |
| DICOMcalibratedluminance | 350cd/m² | Max:800cd/m²Recommend:500cd/m² | C350G has ahigher calibratedluminance thanC270GImage quality isbetter than theimage displayedon the predicatedevice. |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Pixel Pitch | 0.27x0.27 mm | 0.2115x0.2115 mm | C350G has asmaller pixelpitch thanC270G |
| Backlight | LED | LED | Same. |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | same |
| Scanningfrequency (H; V) | 37.9~75kHz;60Hz | 74.2~97.68kHz;60Hz | - |
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | Same |
| Video Signal Input | |||
| Input signals | DVI standard 1.0,DisplayPort 1.2a | DVI standard 1.0,DisplayPort 1.2a | Same |
| Inputterminational | DVI-D x 1,DisplayPort x 1 | DVI-D x 1,DisplayPort x 1 | Same |
| Output signals | - | DisplayPort 1.2a | - |
| Output | - | DisplayPort x 1 | - |
| TerminationalDisplaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| PowerRequirement | DC 24V | DC 24V | Same |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| PowerConsumption/Save Mode | 50W/less than 0.5W | 90W/less than 0.5W | The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerconsumption isdifferent,nothing to dowith the displayfunction |
| PowerManagement | DVI DMPMDisplay Port 1.1a | DVI DMPMDisplay Port 1.2a | Same |
| Miscellaneous Features/Specifications | |||
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | Same |
| Dimensions w/ostand(W x H x D) | Without stand:382mm x490mm x77mmWith stand:382mm x635mm x238mm | Without stand:382mm x490mm x77mmWith stand:363mm x(530-635)mmx238mm | Differenthousing designdue to thedifferent panelsize. |
| Indication foruse | C270G LCD Monitor isintended to be used indisplaying and viewingdigital images for diagnosisof X-ray or MRI, etc. bytrained medical practitioners.The device does not supportthe display of mammographyimages for diagnosis. | C350G LCD monitor isintended to be used indisplaying and viewingdigital images for diagnosisof X-ray or MRI, etc. bytrained medical practitioners.The device is not specifiedfor digital mammographysystem. | Same |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | C270G LCD Monitor | C350G LCD Monitor | |
| 510(k) Number | K183498 | / | |
| Applicablestandard | IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,Medical electrical equipmentPart 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances- Requirements and tests | IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,Medical electrical equipmentPart 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances- Requirements and tests | Same |
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2.2 M550G and its predicate device comparison
This comparison identifies the similarities and differences of the proposed 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 | 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 |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | BARCO MDMG-5221 | M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Viewing angle(H, V) | Horizontal 176 °,Vertical176 ° | Horizontal 178 °,Vertical178 ° | |
| 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 | 2000:1 | M550G has ahigher contrastratio thanMDMG5221Image quality isbetter than theimage displayedon the predicatedevice. |
| DICOMcalibratedluminance | 1000cd/m2 | Max: 1000cd/m²Recommended:500cd/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 LCDMonitor uses acolor bitexpansiontechnology toimprove imagedisplay quality,the image clarityis better than theimage displayedon the predicatedevice. |
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | Same |
| Video Signal Input | |||
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | BARCO MDMG-5221 | M550G LCD Monitor | - |
| 510(k) Number | K161229 | / | - |
| Input signals | DVI standard 1.0,DisplayPort 1.2a | DVI standard 1.0,DisplayPort 1.2a | Same |
| Inputterminational | DVI-D x 1,DisplayPort x 1 | DVI-D x 1,DisplayPort x 1 | Same |
| Output signals | - | DisplayPort 1.2a | - |
| OutputTerminational | - | DisplayPort x 1 | - |
| Displaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| PowerRequirement | AC 100 | DC 24V | Different powersupply, will notaffect theperformance |
| PowerConsumption/Save Mode | 57W/less than 0.7W | 80W/less than 0.5W | The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerconsumption isdifferent,nothing to dowith the displayfunction |
| PowerManagement | DVI DMPMDisplayPort 1.2a | DVI DMPMDisplayPort 1.2a | Same |
| Miscellaneous Features/Specifications | |||
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | BARCO MDMG-5221 | M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Dimensions w/ostand(W x H x D) | Without stand:392mm x484mm x122mmWith stand:780mm x550mm x261mm | Without stand:368mm x474mm x70mmWith stand:368mm x(521-631)mm x238mm | Differenthousing designdue to thedifferent panelsize. |
| Indication foruse | BARCO MDMG-5221device intended to be used indisplaying and viewingdigital images, includingstandard and multi-framedigital mammography, forreview, analysis, anddiagnosis by trained medicalpractitioners. It is speciallyde displaying and viewingdigital images, includingstandard and multi-framedigital mammography, forreview, analysis, anddiagnosis by trained medicalpractitioners. It is speciallydesigned for breasttomosynthesis applications. | M550G LCD Monitor isintended to be used indisplaying and viewingdigital images, includingstandard and multi-framedigital mammography, forreview, analysis, anddiagnosis by trained medicalpractitioners. It is speciallyde displaying and viewingdigital images, includingstandard and multi-framedigital mammography, forreview, analysis, anddiagnosis by trained medicalpractitioners. It is speciallydesigned for breasttomosynthesis applications. | Same |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | BARCO MDMG-5221 | M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Applicablestandard | Electrical Safety test (IEC60601-1) | 1 IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,CFR 47 FCC Part15 subpartB: 2017, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticdisturbances - Requirementsand tests | Same |
| EMC test (IEC 60601-1-2) |
2.3 PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
2.3.1 Bench testing:
Bench testing was conducted to demonstrate the C350G LCD Monitor and M550G LCD Monitor meet 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. .
- Measurement of temporal response ●
- Performance data on luminance stability
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2.3.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the C350G LCD Monitor and M550G LCD Monitor. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
2.3.3 Animal and clinical study
The subject of this premarket submission, C350G LCD Monitor and M550G LCD Monitor, do not require animal or clinical studies to support substantial equivalence.
2.4 CONCLUSIONS
C350G LCD Monitor and M550G LCD Monitor are substantially equivalent to the predicate devices with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the C350G LCD Monitor and M550G LCD Monitor do not raise any new issues of safety or effectiveness.
§ 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).