(107 days)
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, 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 text describes the 510(k) submission for the LG Electronics 32HQ713D Medical Monitor, a device indicated for displaying radiological images. It's important to note that this document does not contain a study proving the device meets acceptance criteria in the way a clinical or AI performance study would. Instead, it demonstrates substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing.
The acceptance criteria are implicitly defined by the functional characteristics and performance parameters expected of a medical monitor for radiological images, particularly for mammography and digital breast tomosynthesis. The performance is demonstrated by comparing these characteristics to established predicate devices and by confirming adherence to relevant standards and guidance documents.
Here's the information extracted and organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are framed as demonstrating equivalence to predicate devices and compliance with relevant standards and guidance. The reported performance is the claim of equivalence based on the measurements.
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (vs. Predicate Device) |
|---|---|
| a. Spatial Resolution | Equivalent to predicate device (TG18 test pattern, MTF measurements). |
| b. Pixel Defects | Equivalent to predicate device (measurements of pixel defects). |
| c. Artifacts (Ghosting/Image Sticking) | Equivalent to predicate device (5x5 mosaic pattern, 64Gray / 127Gray judgment). |
| d. Temporal Response (Rise/Fall Time) | Equivalent to predicate device (5-95% and 40-60% luminance transitions). |
| e. Luminance (Max/Min/Achievable/Recommended) | Equivalent to predicate device (analysis of measured luminance values). |
| f. Conformance to Grayscale-to-Luminance Function | Equivalent to predicate device (mapping between image values and luminance output for 256+ levels). |
| g. Luminance at 30° and 45° (Off-normal viewing) | Equivalent to predicate device (luminance response for off-normal viewing). |
| h. Luminance Uniformity or Mura Test | Equivalent to predicate device (measurements of luminance uniformity across display). |
| i. Stability of Luminance and Chromaticity with Temperature and Time | Equivalent to predicate device (no display off, consistent display quality without temperature impact). |
| j. Spatial Noise | Equivalent to predicate device (noise levels for TG18 test pattern and recommended luminance values). |
| k. Reflection Coefficient | Equivalent to predicate device (measurements of Rd). |
| l. Veiling Glare or Small-Spot Contrast | Equivalent to predicate device (contrast obtained for TG18 test pattern and luminance values). |
| m. Color Tracking | Equivalent to predicate device (sRGB xy coverage measurements). |
| n. Gray Tracking | Equivalent to predicate device (sRGB UV coverage measurements). |
| Electrical Safety & Essential Performance | Complies with IEC 60601-1:2015+A1:2012+A2:2020. |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2:2014. |
| Usability | Complies with IEC 60601-1-6:2010+A1:2013+A2:2020. |
| Software Validation | Designed, verified, and validated according to a software development process (MODERATE level of concern software). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of an "AI test set." This submission describes the testing of a medical monitor (hardware/software), not an AI algorithm. The tests conducted (e.g., spatial resolution, luminance) are on the physical device itself. The document does not specify the number of units tested, but this would typically be a small, representative sample of manufactured devices.
- Data Provenance: Not applicable as there is no patient data involved in these non-clinical performance tests of a display monitor. The tests are based on standard test patterns and measurement methodologies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth in the context of a medical display's performance relates to its physical characteristics and adherence to technical specifications and industry standards (e.g., DICOM Part 14 for Grayscale Standard Display Function). These are objectively measurable and do not require expert human interpretation to establish a "ground truth" in the way an AI diagnostic model would.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was performed or described. This submission is for a medical monitor, not an AI-based diagnostic aid that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As noted, this is a medical display, not an AI algorithm. Its "performance" is its ability to accurately and consistently render images, which is tested directly.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is objective technical specifications and industry standards for medical displays. These include:
- Physical measurements (e.g., luminance, resolution, pixel defects).
- Compliance with electrical safety, EMC, and usability standards (e.g., IEC 60601 series).
- Conformance to display functions like the Greyscale Standard Display Function (implicitly referenced through the "conformance to a grayscale-to-luminance function" test).
- The performance of legally marketed predicate devices, which serve as a benchmark for "substantial equivalence."
8. The Sample Size for the Training Set
Not applicable. This device is a medical monitor, not an AI system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LG Electronics Inc. % Jonghyun Kim Chief Consultant GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 REPUBLIC OF KOREA
Re: K223423
March 1, 2023
Trade/Device Name: 32H0713D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: February 1, 2023 Received: February 3, 2023
Dear Jonghyun Kim:
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) K223423
Device Name 32HQ713D
Indications for Use (Describe)
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, 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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510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
Nov 11, 2022
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • Name of Sponsor: | LG Electronics Inc. |
|---|---|
| - Address: | 222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si,Gyeonggi-do, 17709, Republic of Korea |
| • Contact Name: | Jinhwan Jun / Chief Research Engineer |
| - Telephone No.: | +82-31-8066-5641 |
| - Email Address: | jinhwan.jun@lge.com |
| • Name of Manufacturer: | LG Electronics Inc. |
- 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do, 39368, Address: -Republic of Korea
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: ● 32HQ713D
- . Common Name:
Medical Monitor
- Classification: ●
| Classification Name | Picture archiving and communications system |
|---|---|
| Classification Number | 21 CFR 892.2050 |
| Product Code | PGY |
| Device Class | II |
| Review Panel | Radiology |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Primary Predicate Device
- 510(k) Number:
- Applicant: ●
Classification Name: ●
- Trade Name: ●
Predicate Device
●
.
●
●
- K201777 510(k) Number: Applicant: LG Electronics Classification Name: Picture archiving and communications system Trade Name: 31HN713D
EIZO Corporation
Picture archiving and communications system
RX560
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)]
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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7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
The table below presents comparisons between the subject device (32HQ713D) and the legally marketed predicate devices (K172738 and K201777):
| Proposed Device | Primary Predicate Device | |
|---|---|---|
| K Number | Not known | K172738 |
| Manufacturer | LG Electronics Inc. | EIZO Corporation |
| Model Name | 32HQ713D | RX560 |
| Classification Name | Picture archiving and communications system | Picture archiving and communications system |
| Classification Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indications for Use | 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. | This product is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications. |
| Display Technology | The 32HQ713D has a LB315WR6-SSZ1 module for displaying. The a LB315WR6-SSZ1 is a 31.5" TFT Liquid Crystal Display module with LED Backlight unit and one 30pin eDP port and 1ch-eDP interface. This module supports 3840x2160 Pixel mode and can display color driven by 10bit drivers. The LCD module includes built-in converter for Backlight | This is a color LCD monitor for viewing digital images, including standard and multiframe digital mammography, for review, analysis and diagnosis. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2048x2560 pixels. |
| Power Consumption | MAX. 120WOff Mode ≤ 0.3W | 87 W / Less than 1 W |
| Screen size | 730.70 x 425.20 mm | 337.9 mm x 422.4 mm |
| LCD Screen | TFT LCD | TFT LCD |
| Pixel Pitch | 0.18159 x 0.18159 mm | 0.165 x 0.165 mm |
| Resolution | 3,840 x 2,160 pixels | 2,048 x 2,560 |
| Horizontal Frequency | 30 kHz to 135kHz | 31 kHz to 135 kHz |
| Vertical Frequency | 24 Hz to 61 Hz | 59 Hz to 61 Hz |
| Input video signals | DVI IN x 1,DP IN x 1 | DVI x 1DP IN x 1 |
[Table 1. Comparison of Proposed Device to Primary Predicate Device]
The comparison table shows that the subject device (32HQ713D) has the similar indications for use the primary predicate device. Although the devices have some different technological characteristics (screen size, pixel pitch, Resolution, horizontal/vertical frequency and input video signals), these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does. There are no significant differences in the technological characteristics of the subject device. All the differences between the subject and predicate device do not raise different questions of safety and effectiveness. It is substantially equivalent to a predicate device in indications for use and technology characteristics.
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| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K201777 |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. |
| Model Name | 32HQ713D | 31HN713D |
| Classification Name | Picture archiving and communications system | Picture archiving and communications system |
| Classification Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indications for Use | This Medical Monitor is indicated for usein displaying radiological images(including full-field digital mammographyand digital breast tomosynthesis) forreview, analysis, and diagnosis by trainedmedical practitioners. | This Medical Monitor is indicated for usein displaying radiological images(including full-field digital mammographyand digital breast tomosynthesis) forreview, analysis, and diagnosis by trainedmedical practitioners. |
| Display Technology | The 32HQ713D has a LB315WR6-SSZ1module for displaying. The a LB315WR6-SSZ1 is a 31.5" TFT Liquid Crystal Displaymodule with LED Backlight unit and one30pin eDP port and 1ch-eDP interface.This module supports 3840x2160 Pixelmode and can display color driven by10bit drivers. The LCD module includesbuilt-in converter for Backlight | The 31HN713D has a LB310FTM modulefor displaying. The LB310FTM is a 31"TFT Liquid Crystal Display module withLED Backlight unit. This module supports4,200 x 2,800 pixels and can displaycolor driven by 10bit drivers. |
| Power Consumption | MAX. 120WOff Mode ≤ 0.3W | MAX. 150WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W |
| Screen size | 730.70 x 425.20 mm | 676.9 x 459.7 mm |
| LCD Screen | TFT LCD | TFT LCD |
| Pixel Pitch | 0.18159 x 0.18159 mm | 0.1554 x 0.1554 mm |
| Resolution | 3,840 x 2,160 pixels | 4,200 x 2,800 pixels |
| Horizontal Frequency | 30 kHz to 135kHz | 30 kHz to 135kHz |
| Vertical Frequency | 24 Hz to 61 Hz | 56 Hz to 61 Hz |
| Input video signals | DVI IN x 1,DP IN x 1DP OUT x 1 | DisplayPort x 2HDMI x 1 |
| [Table 2. Comparison of Proposed Device to Predicate Device] | ||
|---|---|---|
The comparison table shows that the subject device (32HQ713D) has the similar indications for use the predicate device. Although the devices have some different technological characteristics (screen size, pixel pitch, Resolution, horizontal/vertical frequency and input video signals), these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does. There are no significant differences in the technological characteristics of the subject device. All the differences between the subject and predicate device do not raise different questions of safety and effectiveness. It is substantially equivalent to a predicate device in indications for use and technology characteristics.
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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
-
· Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2015+COPR. 1:2006+COPR. 2:2007 + A1:2012 +A2:2020
-
· Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014
-
· Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability in accordance with IEC 60601-1-6:2010+A1:2013+A2:2020
-
- Software Validation
The 32HQ713D contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated.
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.
-
- Guidance
Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017
- Guidance
| Measurements | Description | SE Note | |
|---|---|---|---|
| a. Spatial resolution | Measurements of the transferof information from theimage data to the luminancefields at different spatialfrequencies of interesttypically done by reportingthe modulation transferfunction. Non-isotropicresolution properties shouldbe characterized properly byproviding two-dimensionalmeasurements ormeasurements along at leasttwo representative axes. | As demonstrated through thefunction of the resolution forthe TG18 test pattern andthe comparison of MTFmeasurements, thespecification of the proposeddevice is equivalent to thepredicate device. | |
| b. Pixel defects | Measurements (count, types(e.g., sub-pixel or entirepixel, always-on, always-off),and locations (map) of pixeldefects. This is typicallyprovided as a tolerance limit.Pixel defects can interferewith the visibility of smalldetails in medical images. | As demonstrated through themeasurements of the pixeldefects, the specification ofthe proposed device is anequivalent predicate device. | |
| c. Artifacts | Evaluate for image artifactssuch as ghosting and/orimage sticking fromdisplaying a fixed testpattern for a period of time. | Demonstrated through themeasurements of the Using5x5 mosaic pattern, 64Gray /127 Gray judgment, thespecification of the proposed | |
| Measurements | Description | SE Note | |
| d. | Temporal response | Measurements of thetemporal behavior of thedisplay in responding tochanges in image valuesfrom frame to frame. Sincethese transitions are typicallynot symmetric, rise and falltime constants are needed tocharacterize the system.Slow displays can alterdetails and contrast of theimage when large imagestacks are browsed or invideo, panning, and zoomingmodes. | device is equivalence to thatof the predicate device.Demonstrated through themeasurements of the riseand fall time constants for 5-95% and 40-60% luminancetransitions, the specificationof the proposed device isequivalent to that of thepredicate device. |
| e. | Luminance | Measurements of themaximum and minimumluminance that the deviceoutputs as used in theapplication underrecommended conditions andthe achievable values if thedevice is set to expand therange to the limit. | Demonstrated through thefunction of the maximummeasured, minimum,achievable, andrecommended luminancevalues analysis, thespecification of the proposeddevice is equivalence to thatof the predicate device. |
| f. | Conformance to agrayscale-to-luminancefunction | Measurements of themapping between imagevalues and the luminanceoutput following a targetmodel response for 256 ormore levels. | Demonstrated through thefunction of the mappingbetween image values andthe luminance outputfollowing a target modelresponse for 256 or morelevels of analysis, thespecification of the proposeddevice is equivalent to that ofthe predicate device. |
| g. | Luminance at 30° and 45°in diagonal, horizontal,and vertical directions atcenter and four corners | Measurements of theluminance response at off-normal viewing related to thetarget model for theluminance response. | Demonstrated through thefunction of luminanceresponse for luminanceresponse, the specification ofthe proposed device isequivalency to that of thepredicate device. |
| h. | Luminance uniformity orMura test | Measurements of theuniformity of the luminanceacross the display screen. | As demonstrated through themeasurements of theuniformity of the luminanceacross the display screen,the specification of theproposed device is anequivalence predicate device. |
| i. | Stability of luminance andchromaticity responsewith temperature and time | Measurements of the changein luminance andchromaticity response withtemperature and use time. | As demonstrated through themeasurements, there is nodisplay off, and the user cansee the display without |
| Measurements | Description | SE Note | |
| temperature on use time; thespecification of the proposeddevice is an equivalencepredicate device. | |||
| j. | Spatial noise | Measurements of the spatialnoise level as represented bythe noise power spectrumusing an appropriate ratio ofcamera and display pixels.Spatial noise and resolutionaffect the way images arepresented to the viewer andcan alter features that arerelevant to the interpretationprocess of the physician orradiologist. | Demonstrated through thefunction of the noise levelsfor the TG18 test pattern andrecommended luminancevalues analysis, thespecification of the proposeddevice is equivalence to thatof the predicate device. |
| k. | Reflection coefficient | Measurements of thereflection coefficients of thedisplay device. Specular anddiffuse reflection coefficientscan be used as surrogatesfor the full bidirectionalreflection distributionfunction. | As demonstrated through themeasurements of thereflection Coefficient (Rd),the specification of theproposed device is equivalentpredicate device. |
| l. | Veiling glare or small-spotcontrast | Measurements of thecontrast obtained for smalltargets. | Demonstrated through thefunction of the contrastobtained for the TG18 testpattern and recommendedluminance values analysis,the specification of theproposed device isequivalence to that of thepredicate device. |
| m. | Color tracking | Chromaticity at differentluminance levels of primarycolors as indicated by thecolor coordinates in anappropriate units system(e.g., CIE u'v') and the colorgamut enveloped by theprimary colors. | As demonstrated through themeasurements of the sRGBxy coverage, the specificationof the proposed device isequivalent to that of thepredicate device. |
| n. | Gray tracking | Chromaticity at differentluminance levels of grayshades, including the whitepoint, as indicated by thecolor coordinates in anappropriate units system | As demonstrated through themeasurements of the sRGBUV coverage, thespecification of the proposeddevice is equivalent to that ofthe predicate device. |
According to the quidance, we test following performance items:
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According to the above test results, there are no significant performance differences between 32HQ713D and the predicate devices that would adversely affect the use of the product. It has substantially equivalent performance compared to the predicate devices.
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Clinical Test Summary:
No clinical studies were considered necessary and performed.
9. Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification LG Electronics, concludes that the 32HQ713D is substantially equivalent in safety and effectiveness to the predicate devices as described herein.
§ 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).