(29 days)
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 LG Medical Monitor (Model 21HQ613D) is indicated for displaying radiological images, including full-field digital mammography and digital breast tomosynthesis, for review, analysis, and diagnosis by trained medical practitioners.
Here's a breakdown of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "All display characteristics of 21HQ613D have met the pre-determined criteria." These criteria are implicitly defined by the successful "PASS" result for each measurement stated in the Non-Clinical Test Summary. The acceptance criteria are derived from the FDA guidance "Display Devices for Diagnostic Radiology".
| Measurement Category | Description (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| 1. Spatial resolution | Measurements of the transfer of information from the image data to the luminance fields at different spatial frequencies of interest, typically done by reporting the modulation transfer function. Non-isotropic resolution properties should be characterized properly by providing two-dimensional measurements or measurements along at least two representative axes. | PASS |
| 2. Pixel defects | Measurements (count, types (e.g., sub-pixel or entire pixel, always-on, always-off), and locations (map)) of pixel defects. This is typically provided as a tolerance limit. Pixel defects can interfere with the visibility of small details in medical images. | PASS |
| 3. Artifacts | Evaluate for image artifacts such as ghosting and/or image sticking from displaying a fixed test pattern for a period of time. | PASS |
| 4. Temporal response | Measurements of the temporal behavior of the display in responding to changes in image values from frame to frame. Since these transitions are typically not symmetric, rise and fall time constants are needed to characterize the system. Slow displays can alter details and contrast of the image when large image stacks are browsed or in video, panning, and zooming modes. For mammography displays, rise and fall time constants at several (e.g., every 15 levels) grayscale intervals between 0 and 255 should be measured. | PASS |
| 5. Luminance | Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values if the device is set to expand the range to the limit. | PASS |
| 6. Conformance to a grayscale-to-luminance function | Measurements of the mapping between image values and the luminance output following a target model response for 256 or more levels. | PASS |
| 7. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners | Measurements of the luminance response at off-normal viewing related to the target model for the luminance response. | PASS |
| 8. Luminance uniformity or Mura test | Measurements of the uniformity of the luminance across the display screen. | PASS |
| 9. Stability of luminance and chromaticity response with temperature and time of operation (on-time) | Measurements of the change in luminance and chromaticity response with temperature and use time. | PASS |
| 10. Spatial noise | Measurements of the spatial noise level as represented by the noise power spectrum using an appropriate ratio of camera and display pixels. Spatial noise and resolution affect the way images are presented to the viewer and can alter features that are relevant to the interpretation process of the physician or radiologist. | PASS |
| 11. Reflection coefficient | Measurements of the reflection coefficients of the display device. Specular and diffuse reflection coefficients can be used as surrogates for the full bidirectional reflection distribution function. | PASS |
| 12. Veiling glare or small-spot contrast | Measurements of the contrast obtained for small targets. | PASS |
| 13. Color tracking (primary colors and color gamut) | Chromaticity at different luminance levels of primary colors as indicated by the color coordinates in an appropriate units system (e.g., CIE u'v') and the color gamut enveloped by the primary colors. | PASS |
| 14. Gray tracking (gray shades and white point) | Chromaticity at different luminance levels of gray shades, including the white point, as indicated by the color coordinates in an appropriate units system. | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes a "Bench Test Performance Test" where "Physical Laboratory Test items suggested in the FDA guidance 'Display Devices for Diagnostic Radiology' were tested on 21HQ613D." This indicates that the testing was performed on the device itself (LG Medical Monitor, Model 21HQ613D). The sample size is not explicitly stated as a number of devices, but rather relates to the inherent characteristics of a single device under various measurement conditions. The data provenance is from laboratory testing of the physical device by LG Electronics Inc., South Korea. This would be considered prospective testing for the specific device model seeking clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study described is a non-clinical bench test of the display device's performance characteristics, not a study involving human interpretation of images where ground truth would typically be established by expert readers.
4. Adjudication Method for the Test Set:
This information is not applicable to the described study. Adjudication methods are typically used in clinical studies involving multiple readers to resolve discrepancies in diagnoses or assessments. The reported study performed physical laboratory tests with specific objective measurements.
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:
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This submission is for a medical monitor, not an AI-powered diagnostic or assistive tool. The studies focused on the performance of the display hardware itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
A standalone algorithm-only performance study was not done in the context of diagnostic interpretations. The study focused on the performance of a medical display device, which is a "standalone" device in the sense that its performance characteristics are measured independently of a human user making a diagnosis. However, this is not an algorithm performing a diagnostic task.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical bench tests was the objective physical measurements of the display's characteristics against pre-determined engineering and display quality standards outlined in the FDA guidance "Display Devices for Diagnostic Radiology." This is analogous to a reference standard for physical characteristics rather than a clinical diagnosis ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set:
This information is not applicable. The device is a medical monitor, which is hardware for displaying images. It does not utilize a training set in the way a machine learning algorithm would. While its internal calibration tools (LG Calibration Studio Medical and DBI Calibration Feedback System) contain software, these are for maintaining display quality, not for image analysis requiring a training set for diagnostic tasks. The software for these tools was "designed and developed according to a software development process and was verified and validated" according to IEC 62304.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a diagnostic algorithm.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
LG Electronics Inc. Hanseul Park RA Specialist 168, Suchul-Daero Gumi-Si, 39368 Korea. South
Re: K240130
February 15, 2024
Trade/Device Name: Medical Monitor (21HQ613D) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: January 5, 2024 Received: January 17, 2024
Dear Hanseul Park:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K240130
Device Name Medical Monitor (21HQ613D)
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, analysis, and diagnosis by trained medical practitioners.
X 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/1 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.
510(K) Summary
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Image /page/4/Picture/1 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white "L" and "G" inside. To the right of the circle, the words "LG Electronics" are written in gray.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
February 14, 2024
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Applicant: LG Electronics Inc. .
- Address: 168, Suchul-Daero, Gumi-Si, KR 39368 -
- Contact Name: Hanseul Park / RA Specialist -
- Telephone No.: +82-10-9490-2109 -
- Email Address: hs.park@lge.com -
| • Name of Manufacturer: | LG Electronics Inc. |
|---|---|
| - Address: | 168, Suchul-Daero, Gumi-Si, KR 39368 |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Common name | Medical Monitor |
|---|---|
| Trade Name | 21HQ613D |
| Classification Name | Medical image management andprocessing system |
| Classification Product Code | PGY |
| Regulation Number | 21 CFR 892.2050 |
| Device Class | II |
| 510k Review Panel | Radiology |
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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 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.
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
- 510(k) Number: K221061 ●
- Applicant: LG Electronics Inc. ●
- Trade/Device Name: 21HQ613D ●
- Classification Name: Medical image management and processing system
- Regulation Number: 21 CFR 892.2050 ●
- . Classification Product Code: PGY
- Device Class: II ●
- 510(k) Review Panel: Radiology ●
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 fullfield digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
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Image /page/6/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a stylized red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in a gray sans-serif font. The logo is simple and modern, and it is easily recognizable.
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
Compared with the predicate device, the technological characteristics of the proposed device are substantially equivalent to those of the predicate device. The proposed device is functionally similar to the predicate device. The table below presents comparisons for each device:
| Proposed Device | Predicate Device | SE Note | |
|---|---|---|---|
| K Number | K240130 | K221061 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 21HQ613D | 21HQ613D | - |
| ClassificationName | Medical Image management andprocessing system | Medical Image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Indicationsfor Use | This Medical Monitor isindicated for use in displayingradiological images(including full-field digitalmammography and digitalbreast tomosynthesis) forreview, analysis, and diagnosisby trained medical practitioners. | This Medical Monitor isindicated for use in displayingradiological images(including full-field digitalmammography and digitalbreast tomosynthesis) forreview, analysis, and diagnosisby trained medical practitioners. | Same |
| DisplayTechnology | TFT (Thin Film Translator)LCD (Liquid Crystal Display)Screen | TFT (Thin Film Translator)LCD (Liquid Crystal Display)Screen | Same |
| PowerConsumption | MAX. 120WOff Mode ≤ 0.3W | MAX. 120WOff Mode ≤ 0.3W | Same |
| Screen size | 473.4 x 364.5 mm | 473.4 x 364.5 mm | Same |
| Pixel Pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm | Same |
| Resolution | Max.:2,048 x 2,560 pixels @60Hz(This is supported in DP IN 2 portonly)Recommended:2,048 x 2,560 pixels @48Hz(This is supported in DP IN 1 portonly)2,048 x 2,560 pixels @60Hz(This is supported in DP IN 2 portonly) | Max.:2,048 x 2,560 pixels @ 50Hz(This is supported in both DP IN 1 andDP IN 2 ports)Recommended:2,048 x 2,560 pixels @ 50Hz(This is supported in both DP IN 1 andDP IN 2 ports) | Different |
| HorizontalFrequency | 30 kHz to 135kHz | 30 kHz to 135kHz | Same |
| VerticalFrequency | 24 Hz to 61 Hz | 24 Hz to 61 Hz | Same |
| Input videosignals | DVI IN x 1,DP IN x 2DP OUT x 1 | DVI IN x 1,DP IN x 2DP OUT x 1 | Same |
| CalibrationTool | LG Calibration Studio Medical /DBI Calibration FeedbackSystem | PerfectLum | Different |
[Table. Comparison of Proposed Device to Predicate Device]
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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 a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The text is in a simple, sans-serif font and is positioned to the right of the circular logo.
The comparison table shows the proposed device (21HQ613D) has shares the same indications for use as the predicate device. Although there are some technological differences, they do not compromise the safety and performance of the proposed device. The major changes include: 1) calibration tools, which have been validated according to IEC 62304, and 2) its module, which also has been verified and validated through physical laboratory testing conducted according to the FDA Guidance. "Display Devices for Diagnostic Radiology".
Based on the physical laboratory test results and software validation reports, all the differences between the proposed and predicate device do not raise any concerns regarding safety and effectiveness of the device.
Therefore, the proposed device is substantially equivalent to the predicate device in terms of its indications for use and technological characteristics.
8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
The following data were provided in support of the substantial equivalence determination:
-
- Electrical Safety and Electromagnetic Compatibility
The test results demonstrated that the proposed device complies with the following standards:
- Electrical Safety and Electromagnetic Compatibility
-
IEC60601-1 Edition 3.2 2020-08 -
Medical electrical equipment - Part 1: General requirements for basic safety and essential -
-IEC60601-1-2 Edition 4.1 2020-09
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
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Image /page/8/Picture/0 description: The image shows the logo for LG Electronics. The logo consists of a stylized red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The text is written in a sans-serif font and is positioned to the right of the circular logo.
2) Software Validation
21HQ613D contain software that belongs to Basic Documentation Level. The software was designed and developed according to a software development process and was verified and validated.
Its calibration tools, LG Calibration Studio Medical and DBI Calibration Feedback System (CFS), belong to Basic Documentation Level. The software programs were verified and validated according to IEC 62304. Software information is provided in accordance with FDA guidance:
- . The content of premarket submissions for Device Software Functions (June 14, 2023)
-
- Cybersecurity
Cybersecurity documents are provided in accordance with the below FDA guidance:
- · Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 27, 2023)
- . Postmarket Management of Cybersecurity in Medical Devices (December 28, 2016)
-
- Bench Test Performance Test
- · Physical Laboratory Test items suggested in the FDA guidance "Display Devices for Diagnostic Radiology" were tested on 21HQ613D using LG Calibration Studio Medical and DBI Calibration Feedback System.
| Measurement | Description | Test result | |
|---|---|---|---|
| 1. Spatial resolution | Measurements of the transfer of information fromthe image data to the luminance fields at differentspatial frequencies of interest typically done byreporting the modulation transfer function. Non-isotropic resolution properties should becharacterized properly by providing two-dimensional measurements or measurements alongat least two representative axes. | PASS | |
| 2. Pixel defects | Measurements (count, types (e.g., sub-pixel orentire pixel, always-on, always-off), and locations(map)) of pixel defects. This is typically providedas a tolerance limit. Pixel defects can interfere | PASS | |
| with the visibility of small details in medicalimages. | |||
| Evaluate for image artifacts such as ghostingand/or image sticking from displaying a fixed testpattern for a period of time. | |||
| 3. | Artifacts | PASS | |
| Measurements of the temporal behavior of thedisplay in responding to changes in image valuesfrom frame to frame. Since these transitions aretypically not symmetric, rise and fall timeconstants are needed to characterize the system.Slow displays can alter details and contrast of theimage when large image stacks are browsed or invideo, panning, and zooming modes.For mammography displays, you should measurethe rise and fall time constants at several (e.g.,every 15 levels) grayscale intervals between 0 and255. | |||
| 4. | Temporal response | PASS | |
| Measurements of the maximum and minimumluminance that the device outputs as used in theapplication under recommended conditions andthe achievable values if the device is set to expandthe range to the limit. | |||
| 5. | Luminance | PASS | |
| 6. | Conformance to agrayscale-to-luminancefunction | Measurements of the mapping between imagevalues and the luminance output following a targetmodel response for 256 or more levels. | PASS |
| 7. | Luminance at 30° and45° in diagonal,horizontal, and verticaldirections at center andfour corners | Measurements of the luminance response at off-normal viewing related to the target model for theluminance response. | PASS |
| 8. | Luminance uniformityor Mura test | Measurements of the uniformity of the luminanceacross the display screen. | PASS |
| 9. | Stability of luminanceand chromaticityresponse withtemperature and timeof operation (on-time) | Measurements of the change in luminance andchromaticity response with temperature and usetime. | PASS |
| 10. | Spatial noise | Measurements of the spatial noise level asrepresented by the noise power spectrum using anappropriate ratio of camera and display pixels.Spatial noise and resolution affect the way images | PASS |
| are presented to the viewer and can alter featuresthat are relevant to the interpretation process of thephysician or radiologist. | |||
| 11. Reflection coefficient | Measurements of the reflection coefficients of thedisplay device. Specular and diffuse reflectioncoefficients can be used as surrogates for the fullbidirectional reflection distribution function. | PASS | |
| 12. Veiling glare or small-spot contrast | Measurements of the contrast obtained for smalltargets. | PASS | |
| 13. Color tracking(primary colors and colorgamut) | Chromaticity at different luminance levels ofprimary colors as indicated by the colorcoordinates in an appropriate units system (e.g.,CIE u'v') and the color gamut enveloped by theprimary colors. | PASS | |
| 14. Gray tracking (grayshades and white point) | Chromaticity at different luminance levels of grayshades, including the white point, as indicated bythe color coordinates in an appropriate unitssystem | PASS |
Please refer to below table for the summary of its physical laboratory test results.
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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 text "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
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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 "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.
All display characteristics of 21HQ613D have met the pre-determined criteria. Therefore, the performance of the proposed 21HQ613D has been verified through the physical laboratory test.
9. Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
10. Conclusion [21 CFR 807.92(b)(3)]
Based on the information provided in this premarket notification and in accordance with the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807, LG Electronics Inc. has determined that there are no significant differences between the proposed device and the predicate device that would negatively impact its use and safety. The proposed device has been proved to be as safe and effective as the predicate device, which was previously cleared in K221061. It shares the same indications for use and similar technological characteristics, with any differences supported by software validation reports and performance test results that demonstrate the proposed device's safety and effectiveness. Therefore, the technological differences between
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Image /page/11/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
the proposed device and its predicate device do not raise any new concerns regarding safety or effectiveness, and the proposed device can be considered substantially equivalent to the predicate device.
§ 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).