(149 days)
Not Found
No
The summary describes a medical monitor for displaying images, with no mention of AI/ML features or image processing capabilities beyond display.
No
Explanation: This device is a medical monitor used for displaying radiological images for diagnosis, not for providing therapy or treatment.
No
Explanation: The device is a monitor used for displaying images, not for performing the diagnostic analysis itself. The "Intended Use" states it is for "displaying radiological images for review, analysis, and diagnosis," indicating it is a tool for diagnostic activities, but not the diagnostic device itself.
No
The device description explicitly states "Medical monitor" and describes its function as displaying images, which implies a hardware component (the monitor itself). The predicate device is also a physical monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: This device is a medical monitor used for displaying radiological images. It processes and displays images that are already generated by other medical imaging equipment (like X-ray machines, CT scanners, etc.). It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying radiological images for review, analysis, and diagnosis." This is a function related to image visualization and interpretation, not in vitro testing.
Therefore, this medical monitor falls under the category of medical imaging display devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
PGY
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiological images
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)
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 32HL512D 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.
Clinical Test Summary:
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
Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). The logo features a stylized human figure on the left, followed by the acronym "FDA" in a blue square. To the right of the blue square, the words "U.S. FOOD & DRUG" are stacked above the word "ADMINISTRATION", all in blue. The logo is clean and professional, reflecting the organization's role in public health and safety.
LG Electronics Inc. % Jinhwan Jun Chief Research Engineer 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-si, Gyeonggi-do 17709 REPUBLIC OF KOREA
March 13, 2020
Re: K192925
Trade/Device Name: 32HL512D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: February 6, 2020 Received: February 14, 2020
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
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
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Indications for Use
510(k) Number (if known) K192925
Device Name 32HL512D
Indications for Use (Describe)
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.
| 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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510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
February 7, 2020
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. |
| Address: | 77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381, |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| • Trade Name: | 32HL512D |
|---|---|
| --------------- | ---------- |
- . Common Name:
Medical Monitor
Republic of Korea
- 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;
Predicate Device
●
●
●
| 510(k) Number: | K131090 |
|---|---|
| Applicant: | EIZO Corporation |
| Classification Name: | Picture archiving and communications system |
- Trade Name: RadiForce MX215 ●
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 for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
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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 (32HL512D) and the legally marketed predicate device (K131090):
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K131090 |
| Manufacturer | LG Electronics Inc. | EIZO Corporation |
| Model Name | 32HL512D | RadiForce MX215 |
| 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 for review, analysis, and | ||
| diagnosis by trained medical | ||
| practitioners. The display is not | ||
| intended for mammography. | This product is intended to be | |
| used in displaying and viewing | ||
| digital images for review and | ||
| analysis by trained medical | ||
| practitioners. It does not support | ||
| the display of mammography | ||
| images for diagnosis. | ||
| Display Technology | The 32HL512D has a LM315WR2 | |
| module for displaying. The | ||
| LM315WR2 is a 31.5" TFT Liquid | ||
| Crystal Display module with LED | ||
| Backlight unit and one 30-pin | ||
| eDP port has 4 lane eDP | ||
| interface. This module supports | ||
| 3840 x 2160 UHD mode and can | ||
| display color driven by 10bit | ||
| drivers. | RadiForce MX215 is a color LCD | |
| monitor for viewing medical | ||
| images other than those of | ||
| mammography. The color panel | ||
| employs in-plane switching (IPS) | ||
| technology allowing wide | ||
| viewing angles and the matrix | ||
| size (or resolution) is 1,200 x | ||
| 1,600 pixels (2MVP). | ||
| Power Consumption | MAX. 65W | |
| Sleep Mode ≤ 0.5W | ||
| Off Mode ≤ 0.3W | Max. 48W | |
| Standby |