(56 days)
Not Found
No
The document describes a medical monitor for displaying images and mentions image processing, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies focus on display characteristics, not algorithmic performance.
No.
The device is a medical image display monitor used for diagnosis and review by medical practitioners, not for direct therapeutic intervention on a patient.
Yes
The device is indicated for displaying radiological images for review and diagnosis by trained medical practitioners, and for displaying and viewing medical images for diagnosis, including in digital mammography PACS and digital breast tomosynthesis.
No
The device is a physical LCD monitor designed for displaying medical images, not a software-only application. The description explicitly mentions "LCD monitor," "high-luminance LCD panel," and physical performance testing.
Based on the provided information, neither the HMD3C21S nor the HMD5G21S are IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended use and device description clearly state that these monitors are for displaying and viewing radiological images for diagnosis. These images are generated by modalities like X-rays, mammography, etc., which are external imaging techniques, not the analysis of biological specimens.
- The intended use is focused on displaying images for visual interpretation by medical practitioners. This is a crucial distinction from IVD devices, which perform analytical tests on biological samples.
- The performance studies described are related to the display characteristics (luminance, resolution, uniformity, etc.) which are relevant to image quality and viewing, not the analytical performance of a diagnostic test on a biological sample.
In summary, these devices are medical image display monitors, not devices that perform in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
HMD3C21S : The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G21S : The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
The LCD monitor employs high-luminance LCD panel, and is designed for medical image display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners or certified personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The recommended physical laboratory tests were performed on the proposed devices HMD3C21S and HMD5G21S.
Measurements for both devices include:
a. Spatial resolution: By reporting modulation transfer function.
b. Pixel defects (maximum counts, allowed defect types, and locations): Maximum number allowed for each type.
c. Artifacts: Crosstalk and Ghost.
e. Luminance (maximum, minimum, achievable, and recommended): Measure the maximum, minimum, achievable, and recommended luminance.
f. Conformance to a gray scale-to-luminance function (for example, DICOM GSDF): Luminance Response by AAPM-TG18.
Additional measurements for HMD3C21S:
d. Temporal response: Measure the rise and fall time constants for 5 – 95% and 40 - 60% luminance transitions.
m. Color tracking (primary colors and color gamut): Measure the primary colors and color gamut.
Additional measurements for HMD5G21S:
d. Temporal response: Measure the rise and fall time constants at several (e.g. every 15 levels) grayscale intervals between 0 and 255.
g. Luminance at 30° and 45° in diagonal horizontal, and vertical directions at center and four corners: By AAPM TG18.
h. Luminance uniformity or Mura test: Luminance uniformity and Chromaticity uniformity by AAPM TG18.
i. Stability of luminance and chromaticity response with temperature and time of operation or on-time: By AAPM TG18.
j. Spatial noise: By noise power spectrum.
k. Reflection coefficient: By specular reflection coefficient and diffuse reflection coefficient.
l. Veiling glare or small-spot contrast: By AAPM TG18.
n. Gray tracking (gray shades and white points): Measure the maximum chromaticity variation by IEC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains 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.
Qingdao Hisense Medical Equipment Co., Ltd. % Hanson Chen Official Correspondent Shenzhen Joyantech Consulting Co., Ltd. 1713A,17th Floor, Block A, Zhongguan Times Square, Nanshan District, Shenzhen Shenzhen, Guangdong GD755 CHINA
July 26, 2022
Re: K221567
Trade/Device Name: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 5, 2022 Received: May 31, 2022
Dear Hanson Chen:
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
1
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 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221567
Device Name
LCD Monitor HMD3C21S, LCD Monitor HMD5G21S.
Indications for Use (Describe) HMD3C21S :
The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, and diagnosis by trained medical practitioners. The display is not intended for mammography.
HMD5G218 :
The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
| 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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3
Version: A/0
510(k) Summary
1. Contact Details
| 1.1 Applicant information | |
|---|---|
| Applicant Name | Qingdao Hisense Medical Equipment Co., Ltd. |
| Address | No. 399 Songling Road, Laoshan District 266100, Qingdao, |
| Shandong, P. R. China | |
| Phone No. | +86-532-83091111 |
| Contact person | Li Mingcheng |
| Contact person's e-mail | limingcheng@hisense.com |
| Date Prepared | May 5, 2022 |
1.2 Submission Correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd | |
|---|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong, | ||
| 518000, China | ||
| Phone No. | +86-755-86069197 | |
| Contact person | Hanson Chen | |
| Contact person's e-mail | hanson@cefda.com | |
| Website | http://www.cefda.com |
2. Device information
| Trade name | LCD monitor |
|---|---|
| Model | HMD3C21S, HMD5G21S |
| Classification | II |
| Classification name | Medical image management and processing system |
| Product code | PGY |
| Regulation No. | 892.2050 |
3. Legally Marketed Predicate Device
| Trade Name | 3MP Color LCD Monitors C32S+, C32SP+, 3MP Monochrome |
|---|---|
| 510(k) Number | K201211 |
| Product Code | PGY |
| Manufacturer | Shenzhen Beacon Display Technology Co., Ltd. |
| Trade Name | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD |
| Monitor MS-S500 |
| 510(k) Number | K191137 |
|---|---|
| Product Code | PGY |
| Manufacturer | JVC KENWOOD Corporation |
4. Device Description
4
The LCD monitor employs high-luminance LCD panel, and is designed for medical image display.
5. Intended Use/Indication for Use
The 3MP Color LCD Monitor HMD3C21S is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
The 5MP Monochrome LCD Monitor HMD5G21S is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
6. Substantial Equivalence Comparison
- 6.1 HMD3C21S and its predicate device:
| Elements of
| Comparison | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| 510(k) Number | Pending | K201211 | / |
| Manufacturer | Qingdao Hisense Medical | ||
| Equipment Co., Ltd | Shenzhen Beacon Display | ||
| Technology Co., Ltd. | / | ||
| Device | |||
| type/model | HMD3C21S | 3MP Color LCD Monitors | |
| C32S+, C32SP+ | / | ||
| Intended use/ | |||
| Indication for use | The 3MP Color LCD Monitor | ||
| HMD3C21S is indicated for | |||
| use in displaying radiological | |||
| images for review, analysis, | |||
| and diagnosis by trained | |||
| medical practitioners. The | |||
| display is not intended for | |||
| mammography. | The 3MP Color LCD Monitors | ||
| C32S+, C32SP+ are indicated | |||
| for use in displaying radiological | |||
| images for review, analysis, and | |||
| diagnosis by trained medical | |||
| practitioners. The displays are | |||
| not intended for mammography. | Same | ||
| Prescription or | |||
| OTC | RX | RX | Same |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Performance | |||
| testing | FDA guidance "Display devices for Dignostic Radiology" | FDA guidance "Display devices | |
| for Dignostic Radiology" | Same | ||
| Elements of | |||
| Comparison | Candidate Device | Predicate Device | Remarks |
| 510(k) Number | Pending | K201211 | / |
| Manufacturer | Qingdao Hisense Medical | ||
| Equipment Co., Ltd | Shenzhen Beacon | ||
| Display Technology Co., | |||
| Ltd. | / | ||
| Device type/model | HMD3C21S | 3MP Color LCD Monitors | |
| C32S+, C32SP+ | / | ||
| Display technology | Color LCD panel (IPS) | Color (IPS) | Same |
| Screen size | |||
| (Display area) | 540mm/21.3" | ||
| 324.86 x 433.15 mm | 54.1cm/21.3" | ||
| 324.86 x 433.15 mm | Same | ||
| Backlight type | LED | LED | Same |
| Backlighting | 1000 cd/m² | 1000 cd/m² | Same |
| Frame Rate and | |||
| Refresh Rate | |||
| (Scanning | |||
| Frequency) | 60Hz | 59-61Hz | Same |
| Pixel array | |||
| (Resolution or | |||
| Matrix Size) | 1536 x 2048 | 1536 x 2048 | Same |
| Pixel pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | Same |
| Subpixel driving | |||
| (spatial and | |||
| temporal dithering) | NA, no such function. | Not available | / |
| Display interface | |||
| (Input Video | |||
| Signal) | DVI-D x 1, | ||
| Displayport x 1 | DVI-D x 1, | ||
| Displayport x 1 | Same | ||
| Video bandwidth | DVI: 215MHz | ||
| DisplayPort: 215MHz | DVI: 216MHz | ||
| DisplayPort: 216MHz | Similar | ||
| User control | Quality-control software | ||
| The calibration function | Not available | / | |
| Ambient light | |||
| sensing | Built-in ambient light sensor | Ambient light sensor | Same |
| Touch-screen | |||
| technology | NA, the screen is not | ||
| touch-screen. | Not available | / | |
| Luminance | |||
| calibration tools | Front-facing sensor | ||
| Body sensor | |||
| Quality-control software | Integrated optical | ||
| sensor | |||
| External optical sensor | |||
| Calibration software: | |||
| Beacon Monitor | |||
| Manage | Similar | ||
| Elements of | |||
| Comparison | Candidate Device | Predicate Device | Remarks |
| control procedures | Manage | design | |
| scheme | |||
| Software/Firmware: | |||
| Viewing angle | Horizontal: 178° | ||
| Vertical: 178° | 178° / 178° | Same | |
| Response time | |||
| (typical) | 25 ms | 25 ms | Same |
| Contrast ratio | |||
| (typical) | 1500:1 | 1500:1 | Same |
| Display colors | 1073741824 | 1.073 billion | Same |
| Power | |||
| requirements | DC 24V /3.1A | DC 12V /6.67A | Difference |
| between | |||
| voltage and | |||
| electricity | |||
| Maximum power | |||
| consumption | 74.4W | 80W | Difference |
| design | |||
| scheme | |||
| Power save mode | Less than 0.5W | Less than 5W | Difference |
| design | |||
| scheme | |||
| Sensors | Front-facing sensor | ||
| Body sensor | |||
| Ambient light sensor | Backlight sensor | ||
| Integrated front sensor | |||
| Ambient light sensor | Difference | ||
| design | |||
| scheme | |||
| USB ports | USB 2.0 x 3 | USB 2.0: Type-B x 1 | Difference |
| design | |||
| scheme | |||
| Net weight | 10.31 KG | 9.5 KG | Different |
| weight due | |||
| to different | |||
| components | |||
| and parts | |||
| VESA standard | 100 x 100mm | 100 x 100mm | Same |
| Dimensions | 366 x 557~677 x 273, | ||
| 366 x 482 x 63 | 369 x 220 x | ||
| 511.5~596.15 | Different | ||
| housing | |||
| design due | |||
| to the | |||
| different | |||
| panel size | |||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Remarks |
| 510(k) Number | Pending | K191137 | / |
| Manufacturer | Qingdao Hisense Medical | ||
| Equipment Co., Ltd | JVC KENWOOD Corporation | / | |
| Device | |||
| type/model | HMD5G21S | MS-S500 | / |
| Intended use/ | |||
| Indication for | |||
| use | The 5MP Monochrome LCD | ||
| Monitor HMD5G21S is intended | |||
| to be used in displaying and | |||
| viewing medical images for | |||
| diagnosis by trained medical | |||
| practitioners or certified | |||
| personnel. It is intended to be | |||
| used in digital mammography | |||
| PACS, digital breast | |||
| tomosynthesis and modalities | |||
| including FFDM. | MS-S500 is intended to be used | ||
| in displaying and viewing | |||
| medical images for diagnosis by | |||
| trained medical practitioners or | |||
| certified personnel. | |||
| It is intended to be used in digital | |||
| mammography PACS, digital | |||
| breast tomosynthesis and | |||
| modalities including FFDM. | Same | ||
| Prescription or | |||
| ОТС | RX | RX | Same |
| Electrical | |||
| Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Performance | |||
| testing | FDA guidance "Display devices | ||
| for Dignostic Radiology" | FDA guidance "Display devices | ||
| for Dignostic Radiology" | Same |
Table 01: General Comparison Table
5
Version: A/0
6
Version: A/0
6.2 HMD5G21S and its predicate device:
7
Version: A/0
Table 03: General Comparison Table
Table 04: Detailed Comparison Table
| Elements of
| Comparison | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| 510(k) Number | Pending | K191137 | / |
| Manufacturer | Qingdao Hisense Medical | ||
| Equipment Co., Ltd | JVC KENWOOD | ||
| Corporation | / | ||
| Device type/model | HMD5G21S | MS-S500 | / |
| Display technology | Gray scale LCD panel (IPS) | TFT Monochrome LCD | |
| Panel (IPS) | Difference | ||
| between gray | |||
| and | |||
| monochrome | |||
| Screen Size | |||
| (Display Area) | Horizontal: 422.4mm | ||
| Vertical: 337.92mm | Horizontal: 337.92mm | ||
| Vertical: 422.4mm | Same | ||
| Backlight type | LED | LED | Same |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Remarks |
| Brightness | 3000 cd/m² | 3000 cd/m² | Same |
| Frame Rate and | |||
| Refresh Rate | |||
| (Scanning | |||
| Frequency) | 50Hz | Portrait: | |
| Horizontal:129.1KHz | |||
| Vertical:50Hz | |||
| Landscape: | |||
| Horizontal:103.5KHz | |||
| Vertical:50Hz | Difference | ||
| design | |||
| scheme | |||
| Pixel array | |||
| (Resolution or | |||
| Matrix Size) | 2048 x 2560 | 2048 x 2560 | Same |
| Pixel pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm | Same |
| Subpixel driving | |||
| (spatial and | |||
| temporal dithering) | NA, no such function. | Not available | / |
| Display interface | |||
| (Input Video | |||
| Signal) | DVI-D x 1, | ||
| Displayport x 1 | DVI-D x 1, | ||
| Displayport x 1 | Same | ||
| Video bandwidth | DVI : 215MHz | ||
| DisplayPort : 215MHz | Not available | / | |
| User control | Quality-control software | ||
| The calibration function | QA Medivisor / | ||
| Medivisor NX F-CAL | Difference | ||
| design | |||
| scheme | |||
| Ambient light | |||
| sensing | Built-in ambient light sensor | Built-in ambient light | |
| sensor | Same | ||
| Touch-screen | |||
| technology | NA, the screen is not | ||
| touch-screen. | Not available | / | |
| Luminance | |||
| calibration tools | Built-in calibration sensor | ||
| Quality control software | Integrated optical | ||
| sensor | |||
| External optical sensor | |||
| Calibration software: | |||
| Beacon Monitor Manage | Difference | ||
| design | |||
| scheme | |||
| Software/Firmware: | |||
| Viewing angle | Horizontal: 178° | ||
| Vertical: 178° | Horizontal: 178° | ||
| Vertical: 178° | Same | ||
| Aspect ratio | 5:4 | 4:5 | Same |
| Response time | |||
| (typical) | 25 ms | 25 ms | Same |
| Contrast ratio | |||
| (typical) | 2000:1 | 2000:1 | Same |
| Grayscale tones | 256 gray scales/single | 10-bit (DisplayPort): | Difference |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Remarks |
| subpixels (for DP 10-bit | |||
| input) | 1,024 from a palette of | ||
| 16,369 tones | |||
| 8-bit (DVI): 256 from a | |||
| palette of 16,369 tones | design | ||
| scheme | |||
| Power | |||
| requirements | DC 24V, 3.3A | AC 100-240V, 50/60Hz | Difference |
| between | |||
| built-in power | |||
| supply and | |||
| built-out | |||
| power supply | |||
| Maximum power | |||
| consumption | 79.2W | 80W | Difference |
| design | |||
| scheme | |||
| Power save mode | Less than 0.5W | Less than 1W | Difference |
| design | |||
| scheme | |||
| Sensors | Front-facing sensor | ||
| Ambient light sensor | Front sensor | ||
| Ambient light sensor | Same | ||
| USB ports | 1 uplink | ||
| 2 downlink /Rev.2.0 | 1 upstream | ||
| 2 downstream /Rev.2.0 | Same | ||
| Dimensions | 366 x 495~610 x 58, | ||
| 366 x 496 x 58 | 361 x 517/612 x 196.5 | Different | |
| housing | |||
| design due | |||
| to the | |||
| different | |||
| panel size |
8
Version: A/0
9
Version: A/0
7. Performance Testing-Bench
The recommended physical laboratory tests were performed on the proposed devices HMD3C21S and HMD5G21S.
| Measurements | HMD3C21S | HMD5G21S |
|---|---|---|
| a. Spatial resolution | By reporting modulation | |
| transfer function. | By reporting modulation transfer | |
| function. | ||
| b. Pixel defects (maximum counts, | ||
| allowed defect types, and locations) | Maximum number | |
| allowed for each type. | Maximum number allowed for | |
| each type. | ||
| c. Artifacts | Crosstalk and Ghost. | Crosstalk and Ghost. |
| d. Temporal response | Measure the rise and fall | |
| time constants for 5 – | ||
| 95% and 40 - 60% | ||
| luminance transitions. | Measure the rise and fall time | |
| constants at several (e.g. every | ||
| 15 levels) grayscale intervals | ||
| between 0 and 255. |
10
Qingdao Hisense Medical Equipment Co., Ltd.
| Product: LCD monitor | |
|---|---|
| ---------------------- | -- |
Version: A/0
| e. Luminance (maximum, minimum, achievable, and recommended) | Measure the maximum, minimum, achievable, and recommended luminance. | Measure the maximum, minimum, achievable, and recommended luminance. |
|---|---|---|
| f. Conformance to a gray scale-to-luminance function (for example, DICOM GSDF) | Luminance Response by AAPM-TG18. | Luminance Response by AAPM-TG18. |
| g. Luminance at 30° and 45°in diagonal horizontal, and vertical directions at center and four corners | NA | By AAPM TG18. |
| h. Luminance uniformity or Mura test | NA | Luminance uniformity and Chromaticity uniformity by AAPM TG18. |
| i. Stability of luminance and chromaticity response with temperature and time of operation or on-time | NA | By AAPM TG18. |
| j. Spatial noise | NA | By noise power spectrum. |
| k. Reflection coefficient | NA | By specular reflection coefficient and diffuse reflection coefficient. |
| I. Veiling glare or small-spot contrast | NA | By AAPM TG18. |
| m. Color tracking (primary colors and color gamut) | Measure the primary colors and color gamut. | NA, HMD5G21S employs gray scale LCD panel. |
| n. Gray tracking (gray shades and white points) | NA | Measure the maximum chromaticity variation by IEC |
8. Clinical testing
Not applicable.
-
- Other information (such as required by FDA guidance/Test) Not applicable.
10. Conclusions Drawn from Non-Clinical and Clinical Tests
The LCD monitor is substantially equivalent to the legally marketed predicate device 3MP Color LCD Monitors C32S+, C32SP+ (K201211) and 5MP Monochrome LCD Monitor MS-S500 (K191137).