(115 days)
These products are intended to be used in displaying radiological images for review, analysis and diagnosis by trained medical practitioners. They do not support the display of mammography images for diagnosis.
The Hisense LCD monitors are intended for trained medical practitioners and provides the image viewing and medical diagnostic functions. HMD2C21A, HMD4C27S, HMD6C30D are developed with different resolution:1600 x 1200, 2560 x 1440, 3280 × 2080. So the LCD monitors can be used in different environment according to different resolution requirement. The three models also developed with same features such as energy saving, ambient light induction, front-facing sensor calibration, etc. In particular, HMD4C27S, HMD6C30D have body-inductive energy-saving and auto awake function.
The provided text describes the acceptance criteria and the study conducted for the Hisense LCD monitors (HMD2C21A, HMD4C27S, HMD6C30D) to demonstrate substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Hisense LCD monitors are based on demonstrating compliance with performance standards and being substantially equivalent to legally marketed predicate devices. The performance is reported through bench testing in accordance with AAPM Task Group 18 (TG18) guidelines.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Guidance) | Reported Device Performance (HMD2C21A, HMD4C27S, HMD6C30D Measurements) |
|---|---|
| a. Spatial resolution | Measure Spatial resolution with TG18 Resolution |
| b. Pixel defects (maximum counts, allowed defect types, and locations) | Measure Pixel defects with TG18 |
| c. Artifacts | Measure Artifacts with TG18 |
| d. Temporal response | Measure Temporal response with TG18 |
| e. Luminance (maximum, minimum, achievable, and recommended) | Measure Luminance with TG18 |
| f. Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF) | Measure Conformance to a grayscale-to-luminance function with TG18 |
| m. Color tracking (primary colors and color gamut) | Measure Color tracking with TG18 |
| Electrical Safety | Compliance with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 |
Note: The document explicitly states "No" for several other TG18 measurements (g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners; h. Luminance uniformity or Mura test; i. Stability of luminance and chromaticity response with temperature and time of operation or on-time; j. Spatial noise; k. Reflection coefficient; l. Veiling glare or small-spot contrast; n. Gray tracking (gray shades and white point)), indicating these were not considered part of the acceptance criteria for this submission.
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical images or patient data. The performance evaluation was primarily through bench testing of the devices themselves. Therefore, the "sample size" refers to the number of device models tested, which are HMD2C21A, HMD4C27S, and HMD6C30D.
- Sample size: 3 device models (HMD2C21A, HMD4C27S, HMD6C30D).
- Data provenance: Not applicable in the context of patient data. The data originates from physical measurements and tests conducted on the manufactured medical display devices. The study is prospective in the sense that the tests were performed on the devices to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study involved bench testing of display performance against established technical standards (AAPM TG18 guidelines, IEC 60601-1, IEC 60601-1-2), not the establishment of ground truth for medical images by human experts. The "ground truth" for the device's technical specifications is the physical characteristics and performance measurements of the monitors in comparison to the predefined standards and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set involving human interpretation of medical images that would require an adjudication method. The evaluation was based on objective physical and electrical measurements of the display devices.
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, an MRMC comparative effectiveness study was not done. The device is a medical LCD monitor, not an AI-powered diagnostic tool. The submission focuses on the display capabilities of the monitor itself, not on its assistance to human readers or AI performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. The device is a monitor, which by its nature requires a human-in-the-loop (a medical practitioner) to interpret the displayed images. There is no algorithm for diagnostic purposes operating independently on the monitor itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is objective technical specifications and performance metrics defined by international standards and guidelines, such as:
- AAPM Task Group 18 (TG18) guidelines: For display performance characteristics like spatial resolution, pixel defects, artifacts, temporal response, luminance, conformance to DICOM GSDF, and color tracking.
- IEC 60601-1: For electrical safety.
- IEC 60601-1-2: For electromagnetic compatibility (EMC).
- Comparison to predicate devices: The "ground truth" for substantial equivalence is that the proposed device's characteristics and performance are comparable to (or better than, without raising new questions of safety or effectiveness) those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. The device is a medical display monitor, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Qingdao Hisense Medical Equipment Co., Ltd. % Lu Zhonghao Quality Engineer No. 399 Songling Road, Laoshan District Oingdao, Shandong, 266100 CHINA
November 17, 2022
Re: K222208
Trade/Device Name: Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: October 7, 2022 Received: October 18, 2022
Dear Lu Zhonghao:
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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- 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. 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 Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Hisense
LCD monitor( HMD2C21A,HMD4C27S,HMD6C30D)
Indications for Use (Describe)
These products are intended to be used in displaying radiological images for review, analysis and diagnosis by trained medical practitioners. They do not support the display of mammography images for diagnosis.
| 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section5: 510(k) Summary
(K22208)
1. In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date | Oct. 7, 2022 | ||||
|---|---|---|---|---|---|
| Submitter | Qingdao Hisense Medical Equipment Co.,Ltd. | ||||
| Address: No. 399 Songling Road, Laoshan District | |||||
| 266100, Qingdao, Shandong, P. R. China | |||||
| Contact Person: | Primary Contact Person | ||||
| Lu zhonghao | |||||
| Quality Engineer | |||||
| Qingdao Hisense Medical Equipment Co. Ltd. | |||||
| Mail:luzhonghao@hisense.com | |||||
| Tel: +86-532-83091111 | |||||
| Fax:+86-532-83091111 | |||||
| Secondary Contact Person | |||||
| Wu yalan | |||||
| RA Manager | |||||
| Qingdao Hisense Medical Equipment Co. Ltd. | |||||
| Mail: wuyalan@hisense.com | |||||
| Tel: +86-532-83091111 | |||||
| Fax:+86-532-83091111 | |||||
| Device Trade Name: | Hisense LCD monitor HMD2C21A, HMD4C27S,HMD6C30D | ||||
| Common/Usual Name: | 2M/4M/6M Color LCD monitor | ||||
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 | ||||
| Product Code: | PGY | ||||
| No. | Trade Name | 510(k) Number | Product Code | Manufacturer | |
| Predicate Device(s): | 1 | JUSHA-C 270G | K183498 | PGY | Nanjing Jusha Display Technology Co., Ltd |
| 2 | C44W+ | K202374 | PGY | shenzhen Beacon Display Technology Co., Ltd. | |
| 3 | RadiForce RX660 | K163335 | PGY | EIZO Corporation |
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| Device Description: | The Hisense LCD monitors are intended fortrained medical practitioners and provides theimage viewing and medical diagnostic functions.HMD2C21A, HMD4C27S, HMD6C30D aredeveloped with different resolution:1600 x 1200,2560 x 1440, 3280 × 2080. So the LCD monitorscan be used in different environment according todifferent resolution requirement.The three models also developed with samefeatures such as energy saving, ambient lightinduction, front-facing sensor calibration, etc. Inparticular, HMD4C27S, HMD6C30D havebody-inductive energy-saving and auto awakefunction.The Hisense LCD monitor complies withstandards as following:1. EN 60601-1:2006+A1:2013+A12:2014 &IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 Medical electrical equipmentPart 1: General requirements for basic safety andessential performance2. IEC 60601-1-2:2014 & EN 60601-1-2:2015Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard:Electromagnetic disturbances - Requirements andtests. |
|---|---|
| Intended Use: | These products are intended to be used indisplaying radiological images for review, analysisand diagnosis by trained medical practitioners.They do not support the display of mammographyimages for diagnosis. |
| Technology: | 1)HMD2C21A is a 2M color LCD diagnosticmonitor. It strictly complies with the DICOMstandard and has the features of high-resolution,high-brightness display. It uses OSD menusoftware, monitor control software, and qualitycontrol software to achieve functional stability.2) HMD4S27S is a 4M color, one-screen anddual-display diagnostic monitor. It strictly complies |
| Determination of SubstantialEquivalence: | with the DICOM standard and integrates thefunctions of image browsing, reading and writingclinical reports, etc. It uses OSD menu software,monitor control software, and quality controlsoftware to achieve functional stability.3)HMD6C30D is a 6M color, one-screen anddual-display diagnostic monitor. The built-inDICOM standard LUT ensures the long-termstability and consistency of the display, and trulyrestores the original information of the image. Ituses OSD menu software, monitor controlsoftware, and quality control software to achievefunctional stability. |
| Summary of Non-Clinical Tests:The Hisense LCD monitor (HMD2C21A,HMD4C27S, HMD6C30D) complies withstandards as following:1. EN 60601-1:2006+A1:2013+A12:2014 &IEC60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 Medical electrical equipment Part 1:General requirements for basic safety andessential performance2. IEC 60601-1-2:2014 & EN 60601-1-2:2015Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral standard:Electromagnetic disturbances - Requirements andtests.The Hisense LCD monitor HMD2C21A,HMD4C27S, HMD6C30D are substantiallyequivalent to JUSHA-C270G, C44W+, RadiForceRX660. They have equivalent characteristics andfunctions according to comparison table, pleaserefer to 2. Product ComparisonThe following quality assurance measures wereapplied to the development of the system:·Electrical Safety & EMC test·Performance test | |
| Risk Management & Analysis Design Reviews Raw materials verification Final acceptance test etc. Summary of Clinical Tests:The subject of this premarket submission,Hisense LCD monitor, don't require clinicalstudies to support substantial equivalence.The proposed device is Substantially Equivalent(SE) to the predicate device which is US legallymarket device. Therefore, the subject device isdetermined as safe and effectiveness. | |
| Conclusion | Qingdao Hisense Medical Equipment Co., Ltd.Considers the Hisense HMD2C21A, HMD4C27Sand HMD6C30D LCD monitor to be as safe, aseffective, and performance is substantiallyequivalent to the predicate devices. |
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2 Product Comparison
This comparison identifies the similarities and differences of the proposed HMD2 C21A, HMD4C27S and HMD6C30D LCD monitor device to the legally marketed predicate JUSHA-C270G, C44W+ and RadiForce RX660 LCD Monitor.
2.1 HMD2C21A and its predicate
Tabel1 HMD2C21A Detailed Comparison with Predicate
| Elements ofComparison | Proposed device | Predicate Device | ||||
|---|---|---|---|---|---|---|
| ID | 510(k) Number | K222208 | K183498 | |||
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | Nanjing Jusha DisplayTechnology Co., Ltd | ||||
| Devicetype/model | HMD2C21A | JUSHA-C270G | ||||
| 1.Display Performance/Specifications | ||||||
| 1.1 | Screen size | 21,3 inches (540 mm) | 21.3" | |||
| 1.2 | ScreenTechnology | Color LCD panel (IPS) | Color TFT LCD Panel | |||
| 1.3 | Viewing Angle | Horizontal: 178°; vertical: 178°(CR ≥ 10) | Horizontal 178°, Vertical 178° | |||
| 1.4 | Pixel array | 1600 pixels (H) x 1200 pixels(V) | 1600 x 1200/1200 x 1600 |
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| ID | Elements ofComparison | Proposed device | Predicate Device |
|---|---|---|---|
| 510(k) Number | K222208 | K183498 | |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | Nanjing Jusha DisplayTechnology Co., Ltd | |
| Devicetype/model | HMD2C21A | JUSHA-C270G | |
| 1.5 | Display Area | 432 (H) x 324 (V) (mm) | 432.0 (H) x 324.0(V) mm |
| 1.6 | Pixel Pitch | 0.270 (H) x 0.270 (V) (mm) | 0.270x0.270 mm |
| 1.7 | Subpixel driving | Not Applicable | Not Applicable |
| 1.8 | Contrast Ratio | 1800:1 (typ.) | 1400:1 |
| 1.9 | Frame rate | 60Hz | 37.9~75kHz;60Hz |
| 1.10 | MaximumBrightness(typ) | 1000 cd/m² | 1000cd/m² |
| 1.11 | Recommendedbrightness | 400cd/m² | 350cd/m² |
| 1.12 | Backlight type | LED | LED |
| 1.13 | Ambientlightsensing | Built-in ambient light sensor | Ambient luminanceself-adaptation(ABA) |
| 1.14 | Response Time | 16 ms (typ.) | 16 ms(8ms+8ms) |
| 1.15 | Aspect Ratio | 4:3 | 4:3 |
| 1.16 | Luminancecalibration | Front-facing sensorUpper Computer Software | Built in calibration sensorprovided |
| 1.17 | Touch-screen | Not Applicable | Not Applicable |
| 2.Video Signals | |||
| 2.1 | InputVideoSignal | DVI-D x 1DisplayPort x 1 | DVI-D x 1,DisplayPort x 1 |
| 2.2 | Output Signal | DisplayPort x 1 | DisplayPort x1 |
| 2.3 | Video bandwidth | DVI: 215MHzDisplayPort : 215MHz | DVI: 215MHzDisplayPort : 215MHz |
| 3.Power Related Specification | |||
| 3.1 | PowerRequirements | 24 V DC, 1.9A | DC 24V |
| 3.2 | PowerConsumption/save mode | 45.6W/Below 1W | 50W/less than 0.5W |
| 3.3 | PowerManagement | DVI DMPMDisplayPort 1.2a | DVI DMPMDisplayPort 1.1a |
| 4.Miscellaneous Features/Specifications | |||
| ID | Elements ofComparison | Proposed device | Predicate Device |
| 510(k) Number | K222208 | K183498 | |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | Nanjing Jusha DisplayTechnology Co., Ltd | |
| Devicetype/model | HMD2C21A | JUSHA-C270G | |
| 4.1 | USB ports | 1 uplink port and2 downlink ports/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 |
| 4.2 | Display color | 10bit | 16-bit |
| 4.3 | User controls | Off the shelf | Off the shelf |
| 4.4 | Software/Firmware: | Built-in embedded software | Built-in embedded software |
| 4.5 | Dimensions w/ostand(W x H x D) | Without base:384 mm x 492mm x 70mmWith base:384 mm x517.5-637.5 mm x 273.5 mm | Without stand: 382mmx490mm x77mmWith stand: 382mm x635mmx238mm |
| 4.6 | Net weight | 4.3 kg (excluding the base) | 7.5 kg(without stand) |
| 4.7 | VESA standard | 100 x 100 (mm) | 100 x 100 (mm) |
| 5. Intended use | |||
| 5.1 | Indication for use | This product is intended to beused in displaying radiologicalimages for review, analysis anddiagnosis by trainedmedical practitioners.The product does not supportthe display of mammographyimages for diagnosis. | JUSHA-C270G LCD Monitoris intended to be used indisplaying and viewing digitalimages for diagnosis of X-rayor MRI, etc. by trainedmedical practitioners.The device does not supportthe display of mammographyimages for diagnosis. |
| 6 Applicable standard | |||
| 6.1 | Applicablestandard | Compliance with IEC 60601-1Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1Compliance with IEC 60601-1-2 |
| ID | Elements ofComparison | Proposed device | Predicate Device |
| 510(k) Number | K222208 | K202374 | |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | shenzhen Beacon DisplayTechnology Co., Ltd. | |
| Devicetype/model | HMD4C27S | C44W+ | |
| 1.Display Performance/Specifications | |||
| 1.1 | Screen size | 27-inch | 772 mm (30.4") |
| 1.2 | ScreenTechnology | Color LCD panel (IPS) | TFT LCD panel |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical: 178°(CR ≥ 10:1) (typ.) | H:178°, V:178°,(CR>10) |
| 1.4 | Pixel array | 2560 x 1440 | 4MP(2560 x 1600) |
| 1.5 | Display Area | 596.74 (H) x 335.66 (V) (mm) | 641.28 (H) x 400.8 (V) mm |
| 1.6 | Pixel Pitch | 0.2331 x0. 2331 (mm) | 0.2505 x 0.2505 mm |
| 1.7 | Subpixel driving | Not Applicable | Not Applicable |
| 1.8 | Contrast Ratio | 1000:1 (typ.) | 1000:1 |
| 1.9 | Frame rate /refresh rate | 49-76Hz,71.3~112.6kH | 31~140kHz, 29-60Hz |
| 1.10 | MaximumBrightness(typ) | 550cd/m² | 700cd/m² |
| 1.11 | Recommendedbrightness | 400 cd/m² | 500cd/m² |
| 1.12 | Backlight type | LED | LED |
| 1.13 | Ambientlightsensing | Built-in ambient light sensor | Yes |
| 1.14 | Response Time | 16 ms (typ.) | 6ms |
| 1.15 | Aspect Ratio | 16:10 | 16:10 |
| 1.16 | Luminancenon-uniformitycompensation | Not Applicable | Not Applicable |
| 1.17 | Touch-screen | Not Applicable | Not Applicable |
| 2.Video Signals | |||
| 2.1 | Input VideoSignal | DVI-D x 2DisplayPort x 2HDMI | DVI-D x 2DisplayPort x 2VGA×1 |
| 2.2 | Output Signal | DisplayPort | NA |
| ID | Elements ofComparison | Proposed device | Predicate Device |
| 510(k) Number | K222208 | K202374 | |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | shenzhen Beacon DisplayTechnology Co., Ltd. | |
| Devicetype/model | HMD4C27S | C44W+ | |
| 2.3 | Video bandwidth | DVI: 215MHzDisplayPort : 215MHz | DVI: 215MHzDisplayPort : 215MHz |
| 3.Power Related Specification | |||
| 3.1 | PowerRequirements | 24 V DC, 6.25A | DC 24 V/9A |
| 3.2 | PowerConsumption/save mode | 70W/Below 0.5W | 80W/ less than 5W |
| 3.3 | PowerManagement | DVI DMPMDisplayPort 1.2a | DVI DMPM,DisplayPort 1.2a |
| 4.Miscellaneous Features/Specifications | |||
| 4.1 | USB ports | 1 uplink port and2 downlink ports/ Rev. 2.0 | 1 upstream2 downstream/ Rev. 2.0 |
| 4.2 | Display color | 8bit | 10-bit,1,073,741,824color |
| 4.3 | Software/Firmware: | Built-in embedded software | Built-in embedded software |
| 4.4 | Dimensions w/ostand(W x H x D) | Without base:653.8 mm x520mm x 60mmWith base: 653.8 mm x400mm x 60 mm | 699.3 x 513-633 x251.4mmWithout packing864 x600 x334mm(withpacking) |
| 4.5 | Net weight | 8.5 kg (excluding the base) | 13±0.5kg(wet) |
| 4.6 | VESA standard | 100 x 100 (mm) | VESA (100 mm) |
| 5. Intended use | |||
| 5.1 | Indication for use | This product is intended to beused in displaying radiologicalimages for review, analysisand diagnosis by trainedmedical practitioners. Theproduct does not support thedisplayofmammography | These products are intendedto be used in displaying andviewing digital images forreview and analysis bytrained medical practitioners.They do not support thedisplaying of mammography |
| Elements ofComparison | Proposed device | Predicate Device | |
| 510(k) Number | K222208 | K202374 | |
| ID | Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | shenzhen Beacon DisplayTechnology Co., Ltd. |
| Devicetype/model | HMD4C27S | C44W+ | |
| images for diagnosis. | images for diagnosis. | ||
| 6 Applicable standard | |||
| 6.1 | Applicablestandard | Compliance with IEC 60601-1Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1Compliance with IEC 60601-1-2 |
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2.2 HMD4C27S and its predicate
Tabel2 HMD4C27S Detailed Comparison with Predicate
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510(k) Premarket Notification Submission
3.2 HMD6C30D and its predicate
Tabel3 HMD6C30D Detailed Comparison with Predicate
| ID | Elements ofComparison | Proposed device | Predicate Device |
|---|---|---|---|
| 510(k) Number | K222208 | K163335 | |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | EIZO Corporation | |
| Devicetype/model | HMD6C30D | RadiForce RX660 | |
| 1.Display Performance/Specifications | |||
| 1.1 | Screen size | 30 inches | 30" |
| 1.2 | ScreenTechnology | Color LCD panel (IPS) | IPS |
| 1.3 | Viewing Angle | Horizontal: 178°; vertical: 178°(CR ≥ 10) | H: 176°, V: 176° |
| 1.4 | Pixel array | 3280 × 2080 | 6MP (3,280 x 2,048) |
| 1.5 | Display Area | 645.504 (H) × 409.344 (V)(mm) | 645.5 mm x 403.0 mm |
| 1.6 | Pixel Pitch | 0.197 (H) x 0.197 (V) (mm) | 0.1968 mm x 0.1968 mm |
| 1.7 | Subpixel driving | Not Applicable | Not Applicable |
| 1.8 | Contrast Ratio | 2000:1 (typ.) | 1500:1 |
| 1.9 | Frame rate | 48-62Hz | 31 - 127 kHz / 22 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronous mode:29.5 - 30.5 Hz, 59 - 61 Hz |
| 1.10 | MaximumBrightness(typ) | 1300cd/m² | 1000 cd/m² |
| 1.11 | Recommended | 400 cd/m² | 500 cd/m² |
| Elements ofComparison | Proposed device | Predicate Device | |
| 510(k) Number | K222208 | K163335 | |
| ID | Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | EIZO Corporation |
| Devicetype/model | HMD6C30D | RadiForce RX660 | |
| brightness | |||
| 1.12 | Backlight type | LED | LED |
| 1.13 | Ambientlightsensing | Built-in ambient light sensor | Yes |
| 1.14 | Response Time | 30 ms (typ.) | 25ms |
| 1.15 | Aspect Ratio | 16:10 | 16:10 |
| 1.16 | Luminancenon-uniformitycompensation | NA | Digital Uniformity Equalizer |
| 1.17 | Touch-screen | Not Applicable | Not Applicable |
| 2.Video Signals | |||
| 2.1 | VideoInputSignal | DVI-D x 2,DisplayPort x 2,HDMI x 1 | DVI-D (dual link) x 1,DisplayPort x 2 |
| 2.2 | Output Signal | DisplayPort connector | DisplayPort x 1 (daisy chain |
| 2.3 | Video bandwidth | DVI: 215MHzDisplayPort : 215MHz | DVI: 215MHzDisplayPort : 215MHz |
| 3.Power Related Specification | |||
| 3.1 | PowerRequirements | 24 V DC, 6.25 A | AC 100 - 240 V: 50 / 60 Hz |
| 3.2 | PowerConsumption/save mode | 150W/Below 0.5W | 190 W / Less than 1.6 W |
| 3.3 | PowerManagement | DVI DMPMDisplayPort 1.2a | DVI DMPM, DisplayPort 1.2a |
| 4.Miscellaneous Features/Specifications | |||
| 4.1 | USB ports | 1 uplink port and2 downlink ports/ Rev. 2.0 | 2 upstream,3 downstream / Rev. 2.0 |
| 4.2 | Display color | 10bit | 10-bit |
| 4.3 | Software/Firmware | Built-in embedded software | Built-in embedded software |
| ID | Elements ofComparison | Proposed device | Predicate Device |
| 510(k) Number | K222208 | K163335 | |
| Manufacturer | Qingdao Hisense MedicalEquipment Co., Ltd | EIZO Corporation | |
| Devicetype/model | HMD6C30D | RadiForce RX660 | |
| 4.4 | Dimensions w/ostand(W x H x D) | Without base:700 mm x478mm x 68mmWith base:700 mm x 516-626mm x 274 mm | |
| 4.5 | Net weight | 17.1 kg (excluding the base) | 10.1kg(without stand) |
| 4.6 | VESA standard | 100 x 100 (mm) | 100 x 100 (mm) |
| 5. Intended use | |||
| 5.1 | Indication for use | This product is intended to beused in displaying radiologicalimages for review, analysisand diagnosis by trainedmedical practitioners.Theproduct does not support thedisplay of mammographyimages for diagnosis. | The display is intended to beused for displayingandviewing digital images(excluding digitalmammography) for reviewand analysis by trainedmedical practitioners. |
| 6 Applicable standard | |||
| 6.1 | Applicablestandard | Compliance with IEC 60601-1Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1Compliance with IEC 60601-1-2 |
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510(k) Premarket Notification Submission
3.Performance data
The following performance data were provided in support of the substantial equivalence determination.
3.1Bench testing:
The bench tests were performed on the proposed devices HMD2C21A, HMD4C27S, HMD6C30D in accordance with Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline). Bench testing was conducted to demonstrate the HMD2C21A, HMD4C27S, HMD6C30D meets all performance standards as follows:
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510(k) Premarket Notification Submission
| Table4 Bench test | ||||||
|---|---|---|---|---|---|---|
| Measurements Guidance | Recommended forNon-mammographyDisplay Submissions | HMD2C21A,HMD4C27S,HMD6C30DMeasurements | ||||
| a. Spatial resolution | Yes | Measure Spatial resolutionwith TG18 Resolution | ||||
| b. Pixel defects (maximumcounts, allowed defect types,and locations) | Yes | Measure Pixel defects withTG18 | ||||
| c. Artifacts | Yes (Limited) | Measure Artifacts withTG18 | ||||
| d. Temporal response | Yes | Measure Temporalresponse with TG18 | ||||
| e. Luminance (maximum,minimum, achievable, andrecommended) | Yes | Measure Luminance withTG18 | ||||
| f. Conformance to agrayscale-to-luminancefunction (e.g., DICOM GSDF) | Yes | Measure Conformance to agrayscale-to-luminancefunction with TG18 | ||||
| g. Luminance at 30° and 45° indiagonal, horizontal, andvertical directions at center andfour corners | No | - | ||||
| h. Luminance uniformity orMura test | No | - | ||||
| i. Stability of luminance andchromaticity response withtemperature and time ofoperation or on-time | No | - | ||||
| j. Spatial noise | No | - | ||||
| k. Reflection coefficient | No | - | ||||
| I. Veiling glare or small-spotcontrast | No | - | ||||
| m. Color tracking (primarycolors and color gamut) | Yes | Measure Color trackingwith TG18 | ||||
| n. Gray tracking (gray shadesand white point) | No | - |
3.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the HMD2C21A, HMD4C27S, HMD6C30D. The devices comply with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
3.3Animal and clinical study
The subject of this premarket submission, Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D do not require animal or clinical studies to support substantial equivalence.
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4. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Qingdao Hisense Medical Equipment Co., Ltd. concludes that:
- O The intended uses of proposed devices (HMD2C21A, HMD4C27S, HMD6 C30D) are equivalent to the predicate devices.
- The technological characteristics differences between proposed devices ● (HMD2C21A, HMD4C27S, HMD6C30D) and the predicate devices do not affect the safety and effectiveness, so no new risk is raised.
- . Demonstrated by the bench tests, the display characteristics of proposed devices (HMD2C21A, HMD4C27S, HMD6C30D) are equivalent to those of the predicate devices.
§ 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).