(29 days)
21HQ513D, 32HL512D: This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
31HN713D, 32HO713D: This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
The provided document describes the acceptance criteria and the results of the study for the medical monitors 21HQ513D, 32HL512D, 31HN713D, and 32HQ713D.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
The document refers to the "performance items suggested in the FDA guidance 'Display Devices for Diagnostic Radiology'" as the acceptance criteria. The performance for each measurement is uniformly reported as "Pass" for the tested items.
| Measurements | Acceptance Criteria (Implied by FDA Guidance) | Reported Device Performance |
|---|---|---|
| a. Spatial resolution | Meet FDA guidance standards | Pass |
| b. Pixel defects | Meet FDA guidance standards | Pass |
| c. Artifacts | Meet FDA guidance standards | Pass |
| d. Temporal response | Meet FDA guidance standards | Pass |
| e. Luminance | Meet FDA guidance standards | Pass |
| f. Conformance to a grayscale-to-luminance function | Meet FDA guidance standards | Pass |
| g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| h. Luminance uniformity or Mura test | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| i. Stability of luminance and chromaticity response with temperature and time of operation (on-time) | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| j. Spatial noise | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| k. Reflection coefficient | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| l. Veiling glare or small-spot contrast | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
| m. Color tracking | Meet FDA guidance standards | Pass |
| n. Gray tracking | Meet FDA guidance standards | Pass (for 31HN713D, 32HQ713D) / N/A (for 21HQ513D, 32HL512D) |
Note: The "N/A" for certain measurements for models 21HQ513D and 32HL512D might indicate that these tests were not applicable or not performed for these specific models, possibly due to their differing indications for use (not intended for mammography, unlike 31HN713D and 32HQ713D). The document does not explicitly state the acceptance numerical values for each criterion but implies compliance with the FDA guidance "Display Devices for Diagnostic Radiology".
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or images. The study described is a non-clinical bench test on the display devices themselves. The sample size for the test set would be the number of devices tested, which is implied to be one of each model (21HQ513D, 32HL512D, 31HN713D, and 32HQ713D). The data provenance is not applicable in the typical sense of clinical data, as it's a technical performance test of hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study is a non-clinical bench test of display performance against predefined technical standards and FDA guidance, not a study involving expert interpretation of medical images.
4. Adjudication method for the test set
This information is not applicable. There was no expert adjudication process as it was a technical performance test.
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 comparative effectiveness study was done. The device is a medical monitor, not an AI-powered diagnostic tool. The document explicitly states: "No clinical studies were considered necessary and performed."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical monitor, not an algorithm or AI system. The study focused on the technical performance of the monitors.
7. The type of ground truth used
For the bench test, the ground truth was based on the performance items suggested in the FDA guidance "Display Devices for Diagnostic Radiology." This refers to quantifiable technical specifications and standards for medical image displays.
8. The sample size for the training set
This is not applicable. The device is a medical monitor, not a machine learning algorithm that requires a training set. The software components underwent validation according to IEC 62304.
9. How the ground truth for the training set was established
This is not applicable, as there was no training set for an AI algorithm. The validation of the software was done according to IEC 62304, which involves verifying the software against its design specifications and requirements.
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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 side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
LG Electronics Inc. % Daseul An RA Specialist 168. Suchul-daero Gumi-si. Gyeongsangbuk-do 39368 REPUBLIC OF KOREA
August 15, 2023
Re: K232127
Trade/Device Name: 21HQ513D, 32HL512D, 31HN713D, 32HQ713D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: July 10, 2023 Received: July 17, 2023
Dear Daseul An:
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 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
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K232127
Device Name 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
Indications for Use (Describe) 21HQ513D, 32HL512D
This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
31HN713D, 32HO713D
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for LG Electronics. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The text is in a simple, sans-serif font.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
July 11, 2023
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Name of Sponsor: | LG Electronics Inc. |
|---|---|
| Address: | 222, LG-ro, Jinwi-myeon, Pyeongtaek-si,Gyeonggi-do, 17709, Republic of Korea |
| Name of Manufacturer: | LG Electronics Inc. |
| Address: | 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do, 39368Republic of Korea |
| Contact Name: | Daseul An / Regulatory Affairs Specialist |
| Telephone No.: | +82-10-8914-0116 |
| Email Address: | daseul.an@lge.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: 21HQ513D, 32HL512D, 31HN713D, 32HQ713D ●
- Common Name: .
Medical Monitor
- Classification: ●
| Classification Name | Medical image management and processing system |
|---|---|
| Classification Number | 21 CFR 892.2050 |
| Product Code | PGY |
| Device Class | II |
| Review Panel | Radiology |
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Image /page/4/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" inside, next to the text "LG Electronics" in gray. The "L" in the circle is designed to resemble a smiling face, with the dot above the "L" representing an eye.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate Device for 21HQ513D
| • | 510(k) Number: | K223789 |
|---|---|---|
| • | Applicant: | LG Electronics |
| • | Classification Name: | Medical image management and processing system |
| • | Trade Name: | 21HQ513D |
Predicate Device for 32HL512D, 31HN713D, 32HQ713D
| • 510(k) Number: | K230845 |
|---|---|
| • Applicant: | LG Electronics |
| • Classification Name: | Medical image management and processing system |
| • Trade Name: | 32HL512D, 31HN713D, 32HQ713D |
5. Description of the Device [21 CFR 807.92(a)(4)]
The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
6. Indications for use [21 CFR 807.92(a)(5)]
- 21HQ513D, 32HL512D
This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diaqnosis by trained medical practitioners. The display is not intended for mammography.
- 31HN713D, 32HQ713D
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
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Image /page/5/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and the colors are eye-catching.
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
The comparison table shows the technical characteristics of the subject device are substantially equivalent to the predicate device. There are no significant differences between the subject devices and the primary predicate devices that would adversely affect the use of the product. The main change is the addition of the available calibration tool which is validated according to IEC 62304.
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | TBD | K223789 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 21HQ513D | 21HQ513D | - |
| ClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Indications for Use | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | Same |
| Power | MAX. 120W | MAX. 120W | Same |
| Consumption | Off Mode ≤ 0.3W | Off Mode ≤ 0.3W | Same |
| LCD Screen | TFT LCD | TFT LCD | Same |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | Same |
| Resolution | 1,536 x 2,048 pixels | 1,536 x 2,048 pixels | Same |
| HorizontalFrequency | 30 kHz to 130 kHz | 30 kHz to 130 kHz | Same |
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DisplayPort x 2DVI-IN x 1 | DisplayPort x 2DVI-IN x 1 | Same |
| Calibration Tool | PerfectLum / LG Calibration StudioMedical / Calibration FeedbackSystem | PerfectLum / LG Calibration StudioMedical | Modified |
Table 1. Comparison of Proposed Device to Primary Predicate Device (21HQ513D)
Table 2. Comparison of Proposed Device to Primary Predicate Device (32HL512D)
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | TBD | K230845 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 32HL512D | 32HL512D | - |
| ClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
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Image /page/6/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The text is in a sans-serif font and is aligned to the right of the circular logo.
| Indications for Use | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | Same |
|---|---|---|---|
| PowerConsumption | MAX. 65WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W | MAX. 65WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W | Same |
| Screen size | 718.2 x 414.3 mm | 718.2 x 414.3 mm | Same |
| LCD Screen | TFT LCD | TFT LCD | Same |
| Pixel Pitch | 0.18159 x 0.18159 mm | 0.18159 x 0.18159 mm | Same |
| Resolution | 3,840 x 2,160 pixels | 3,840 x 2,160 pixels | Same |
| HorizontalFrequency | 30 kHz to 135 kHz | 30 kHz to 135 kHz | Same |
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DisplayPort x 2HDMI x 1 | DisplayPort x 2HDMI x 1 | Same |
| Calibration Tool | PerfectLum / LG Calibration StudioMedical / Calibration FeedbackSystem | PerfectLum / LG Calibration StudioMedical | Modified |
Table 3. Comparison of Proposed Device to Primary Predicate Device (31HN713D)
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | TBD | K230845 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 31HN713D | 31HN713D | - |
| ClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Indications for Use | This Medical Monitor is indicatedfor use in displaying radiologicalimages (including full-field digitalmammography and digital breasttomosynthesis) for review, analysis,and diagnosis by trained medicalpractitioners. | This Medical Monitor is indicatedfor use in displaying radiologicalimages (including full-field digitalmammography and digital breasttomosynthesis) for review, analysis,and diagnosis by trained medicalpractitioners. | Same |
| PowerConsumption | MAX. 150WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W | MAX. 150WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W | Same |
| Screen size | 676.9 x 459.7 mm | 676.9 x 459.7 mm | Same |
| LCD Screen | TFT LCD | TFT LCD | Same |
| Pixel Pitch | 0.1554 x 0.1554 mm | 0.1554 x 0.1554 mm | Same |
| Resolution | 4,200 x 2,800 pixels | 4,200 x 2,800 pixels | Same |
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Image /page/7/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
| HorizontalFrequency | 30 kHz to 175 kHz | 30 kHz to 175 kHz | Same |
|---|---|---|---|
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DisplayPort x 2HDMI x 1 | DisplayPort x 2HDMI x 1 | Same |
| Calibration Tool | PerfectLum / LG Calibration StudioMedical / Calibration FeedbackSystem | PerfectLum / LG Calibration StudioMedical | Modified |
Table 4. Comparison of Proposed Device to Primary Predicate Device (32HQ713D)
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | TBD | K230845 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 32HQ713D | 32HQ713D | - |
| ClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Indications for Use | This Medical Monitor is indicatedfor use in displaying radiologicalimages (including full-field digitalmammography and digital breasttomosynthesis) for review, analysis,and diagnosis by trained medicalpractitioners. | This Medical Monitor is indicatedfor use in displaying radiologicalimages (including full-field digitalmammography and digital breasttomosynthesis) for review, analysis,and diagnosis by trained medicalpractitioners. | Same |
| PowerConsumption | MAX. 120WOff Mode ≤ 0.3W | MAX. 120WOff Mode ≤ 0.3W | Same |
| Screen size | 730.7 x 425.2 mm | 730.7 x 425.2 mm | Same |
| LCD Screen | TFT LCD | TFT LCD | Same |
| Pixel Pitch | 0.18159 x 0.18159 mm | 0.18159 x 0.18159 mm | Same |
| Resolution | 3,840 x 2,160 pixels | 3,840 x 2,160 pixels | Same |
| HorizontalFrequency | 30 kHz to 135kHz | 30 kHz to 135kHz | Same |
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DVI IN x 1,DP IN x 1DP OUT x 1 | DVI IN x 1,DP IN x 1DP OUT x 1 | Same |
| Calibration Tool | PerfectLum / LG Calibration StudioMedical / Calibration FeedbackSystem | PerfectLum / LG Calibration StudioMedical | Modified |
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Image /page/8/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the words "LG Electronics" in gray. The "L" and "G" are designed to resemble a winking face, with the "L" forming the nose and the "G" forming the face.
8. Non-Clinical Test summary
-
- Electrical Safety and Electromagnetic Compatibility
The test results demonstrated that the proposed device complies with the following standards:
- Electrical Safety and Electromagnetic Compatibility
-
IEC 60601-1:2005/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromaqnetic disturbances -Requirements and tests
-
- Software Validation
The 21HQ513D, 32HL512D, 31HN713D and 32HQ713D contain a MODERATE level of concern software, The software was designed and developed according to a software development process and was verified and validated. There have been firmware updates since FDA 510(K) clearance.
The LG Calibration Studio Medical, PerfectLum and Calibration Feedback System are moderate level of concern software programs. The software programs were verified and validated according to IEC 62304.
- -The software information is provided in accordance with FDA quidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005
3) Bench Test – Performance Test Report
The performance items suggested in the FDA quidance "Display Devices for Diagnostic Radiology" were tested on the 21HQ513D, 32HL512D, 31HN713D and 32HQ713D using Calibration Feedback System.
| Measurements | Test Result | |
|---|---|---|
| a. | Spatial resolution | Pass |
| b. | Pixel defects | Pass |
| c. | Artifacts | Pass |
| d. | Temporal response | Pass |
| e. | Luminance | Pass |
| f. | Conformance to a grayscale-to-luminance function | Pass |
| g. | Luminance at 30° and 45° in diagonal, horizontal, andvertical directions at center and four corners | N/A |
| h. | Luminance uniformity or Mura test | N/A |
| i. | Stability of luminance and chromaticity response withtemperature and time of operation (on-time) | N/A |
| j. | Spatial noise | N/A |
| k. | Reflection coefficient | N/A |
| l. | Veiling glare or small-spot contrast | N/A |
| m. | Color tracking | Pass |
| n. | Gray tracking | N/A |
- -21HQ513D
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Image /page/9/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the words "LG Electronics" in gray. The text is in a sans-serif font and is slightly blurred.
32HL512D -
| Measurements | Test Result | |
|---|---|---|
| a. | Spatial resolution | Pass |
| b. | Pixel defects | Pass |
| c. | Artifacts | Pass |
| d. | Temporal response | Pass |
| e. | Luminance | Pass |
| g. | Luminance at 30° and 45° in diagonal, horizontal, and | N/A |
| vertical directions at center and four corners | N/A | |
| h. | Luminance uniformity or Mura test | N/A |
| i. | Stability of luminance and chromaticity response with | N/A |
| temperature and time of operation (on-time) | N/A | |
| j. | Spatial noise | N/A |
| k. | Reflection coefficient | N/A |
| l. | Veiling glare or small-spot contrast | N/A |
| m. | Color tracking | Pass |
| n. | Gray tracking | N/A |
31HN713D -
| Measurements | Test Result | |
|---|---|---|
| a. | Spatial resolution | Pass |
| b. | Pixel defects | Pass |
| c. | Artifacts | Pass |
| d. | Temporal response | Pass |
| e. | Luminance | Pass |
| f. | Conformance to a grayscale-to-luminance function | Pass |
| g. | Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners | Pass |
| h. | Luminance uniformity or Mura test | Pass |
| i. | Stability of luminance and chromaticity response with temperature and time of operation (on-time) | Pass |
| j. | Spatial noise | Pass |
| k. | Reflection coefficient | Pass |
| l. | Veiling glare or small-spot contrast | Pass |
| m. | Color tracking | Pass |
| n. | Gray tracking | Pass |
32HQ713D -
| Measurements | Test Result | |
|---|---|---|
| a. Spatial resolution | Pass | |
| b. Pixel defects | Pass | |
| c. Artifacts | Pass | |
| d. Temporal response | Pass | |
| e. Luminance | Pass | |
| f. | Conformance to a grayscale-to-luminance function | Pass |
| g. Luminance at 30° and 45° in diagonal, horizontal, and | Pass |
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Image /page/10/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white "L" and "." inside, next to the gray text "LG Electronics". The logo is simple and modern, and it is easily recognizable.
| Measurements | Test Result | |
|---|---|---|
| vertical directions at center and four corners | ||
| h. | Luminance uniformity or Mura test | Pass |
| i. | Stability of luminance and chromaticity response withtemperature and time of operation (on-time) | Pass |
| j. | Spatial noise | Pass |
| k. | Reflection coefficient | Pass |
| l. | Veiling glare or small-spot contrast | Pass |
| m. | Color tracking | Pass |
| n. | Gray tracking | Pass |
All display characteristics of the 21HQ513D, 32HL512D, 31HN713D and 32HQ713D have met the pre-defined criteria. Therefore, the performance of the 21HQ513D, 32HL512D, 31HN713D and 32HQ713D were verified through the performance test.
Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on September 28, 2022
Clinical Test Summary:
No clinical studies were considered necessary and performed.
9. Conclusion [21 CFR 807.92(b)(3)]
The Medical Monitor 21HQ513D, 32HL512D, 31HN713D and 32HQ713D are found to be substantially equivalent in safety and effectiveness to the predicate devices based on the information provided in this premarket notification.
§ 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).