(146 days)
Not Found
No
The summary describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is a medical monitor intended for displaying, reviewing, and analyzing medical images, which is a diagnostic function, not a therapeutic one.
Yes
The device description explicitly states, "It can be used for diagnostic viewing or normal reviewing purpose of medical images."
No
The device description explicitly states it is a "21.3" LCD display," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying, reviewing, and analysis of medical images." This is a function related to visualizing and interpreting images, not performing tests on biological samples to diagnose conditions.
- Device Description: The description confirms it's an "LCD display for medical viewing." This reinforces its role as a display device, not a diagnostic test kit or instrument that analyzes samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing diagnostic results based on sample analysis
The device is a medical monitor used by trained practitioners to view medical images, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. The display is not intended for mammography.
Product codes
PGY
Device Description
The 21HK512D is a 21.3" LCD display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc.
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
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)
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 5, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue.
LG Electronics Inc. % Jinhwan Jun Chief Research Engineer 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-si, Gyeonggi-do 17709 REPUBLIC OF KOREA
Re: K191864
Trade/Device Name: 21HK512D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: September 30, 2019 Received: October 7, 2019
Dear Jinhwan Jun:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191864
Device Name 21HK512D
Indications for Use (Describe)
This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images. The display is not intended for mammography.
| 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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Image /page/3/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face within a circle and the letters "LG" in a sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller font. The face and the circle are in a shade of red, while the letters and the slogan are in gray.
222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, Republic of Korea Tel: +82-31-8066-5641
510(k) Summary
[As Required by 21 CFR 807.92]
K191864
1. Date of submission
July 5, 2019
2. Submitter's Information
| • 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. |
| - Address: | 77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381, |
| Republic of Korea |
3. Trade Name, Common Name, Classification
- Trade Name: ● 21HK512D
- 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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Image /page/4/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face within a circle on the left, and the letters "LG" in gray on the right. Below the letters "LG" is the slogan "Life's Good" in a smaller font.
4. Identification of Predicate Device(s)
The identified predicate device within this submission are shown as follow:
Predicate Device
- 510(k) Number: K153354
- Applicant: EIZO Corporation
- Classification Name: Picture archiving and communications system ●
- Trade Name: RadiForce RX350
5. Description of the Device
The 21HK512D is a 21.3" LCD display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc.
6. Indications for Use
This Medical Monitor is intended to be used by trained medical practitioners for displaying, and analysis of medical images. The display is not intended for mammography.
7. Determination of Substantial Equivalence
The comparison table shows that the subject device (21HK512D) has the same intended use as the predicate one. Although the devices have some different technological characteristics, 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. It is substantially equivalent to a predicate device in indications for use and technology characteristics.
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Image /page/5/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face in a circle and the letters "LG" in a bold, sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller, lighter font.
222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, Republic of Korea Tel: +82-31-8066-5641
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K153354 |
| Manufacturer | LG Electronics Inc. | EIZO Corporation |
| Model Name | 21HK512D | RadiForce RX350 |
| Classification Name | Picture archiving and | Picture archiving and |
| communications system | communications system | |
| Classification Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indications for Use | This Medical Monitor is intended | |
| to be used by trained medical | ||
| practitioners for displaying, | ||
| reviewing, and analysis of | ||
| medical images. The display is | ||
| not intended for mammography. | This product is intended to be | |
| used in displaying and viewing | ||
| digital images for review, | ||
| analysis and diagnosis by trained | ||
| medical practitioners. It does not | ||
| support the display of | ||
| mammography images for | ||
| diagnosis. | ||
| LCD Screen | TFT LCD | TFT LCD |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm |
| Resolution | 2,048 x 1,536 pixels | 1,536 x 2.048 pixels |
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Image /page/6/Picture/0 description: The image shows the logo for LG. The logo consists of a red circle with the letters "L" and "G" inside, and the letters "LG" in gray next to the circle. Below the letters "LG" is the phrase "Life's Good" in a smaller font.
Non-Clinical Test Summary
-
- Electrical Safety and Electromagnetic Compatibility The test results demonstrated that the proposed device complies with the following standards:
- = Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD1:2012
- = Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2 Edition 4.0:2014
- 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
-
- Software Validation
The 21HK512D contains MODERATE level of concern 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.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
8. Conclusion
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 21HK512D is substantially equivalent in safety and effectiveness to the predicate devices as described herein.