(63 days)
Not Found
No
The summary describes a standard digital X-ray detector and image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks.
No
This device is an X-ray imaging device used for diagnosis, not for treating conditions.
Yes
Explanation: The device is described as being used to acquire and process X-ray images for "radiological diagnosis," and it is indicated for "general purpose diagnostic procedures."
No
The device is described as a "Flat Panel Digital X-ray Detector" and utilizes physical components like amorphous silicon and a scintillator to acquire X-ray images. It is a hardware device that connects to a PC and X-ray generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "digital imaging solution designed for general radiographic system for human anatomy." This describes an in vivo imaging device, meaning it's used to image the inside of a living body.
- Device Description: The description reinforces this by stating it's an "x-ray imaging device" that "can acquire and process X-ray images as digital images." X-ray imaging is an in vivo diagnostic technique.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests in vitro (outside of the body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to capture images of the human anatomy using X-rays, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Flat Panel Digital X-ray Detector 14HQ721G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Product codes
MQB
Device Description
This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp highdefinition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device. This device must be used in conjunction with an operating PC and an X-ray qenerator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection. This device does not have a dynamic exposure feature.
14HQ721G-B is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography or dental applications. We understand the Agency has become aware of situations where solid state detectors inserted into radiographic systems adversely impacted device performance due to improper integration.
Below is a summary of the information from the 14HQ721G-B user manuals covering key electromechanical and computer requirements needed for X-ray system interface and integration.
-
- Mechanical interface requirements.
- Computer requirements 2.
-
- Data communication interface requirements
-
- Electrical power requirements
-
- X-ray trigger interface requirements
Neither the 14HQ721G-B nor its software acts as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements.
The built-in AEC (Automatic Exposure Control) in 14HQ721G-B is sensors which convert the amount of the X-ray emitted from the X-ray generator into the electric signals and deliver them to the X-ray generator connected with the X-ray detector via the control box. The X-ray generator determines for itself whether to stop x-ray emission based on these electrical signals. The 14HQ721G-B does not directly control the X-ray generator.
Mentions image processing
This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy / General
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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, Electromagnetic Compatibility and Performance: The 14HQ721G-B complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Software Validation: The 14HQ721G-B includes the software of MODERATE level of concern as a firmware. The difference from the predicate device is the addition of the AEC mode. The software was designed and developed according to the internal software development process and was verified and validated.
- Biocompatibility: . ISO 10993-1 and series, Biological evaluation of medical devices
- Performance Test: Imaging performance test was conducted according to IEC 62220-1-1, Medical Electrical Equipment Characteristics of Digital X-ray Imaging Devices ● Part 1-1: Determination of the Detective Quantum Efficiency – Detectors Used in Radiographic Imaging.
- Cybersecurity
The proposed device (14HQ721G-B) has shown similar performance (DQE, MTF) as the predicate device.
DQE: Typ.66% @0.1lp/mm
MTF: Typ.84% @0.5lp/mm
Resolution: 3.6lp
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
January 27, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the agency's acronym in a blue square, followed by the full name "U.S. Food & Drug Administration" in blue text.
LG Electronics Inc. % Daseul An RA associate 222, LG-RO PYEONGTAEK-SI, GYEONGGI-DO 17709 REPUBLIC OF KOREA
Re: K223546
Trade/Device Name: 14H0721G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: November 25, 2022 Received: November 25, 2022
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
1
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 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,
2023.01.27
Lu Jiang 11:30:39
-05'00'
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems 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
2
Indications for Use
510(k) Number (if known) K223546
Device Name 14HQ721G-B
Indications for Use (Describe)
The Flat Panel Digital X-ray Detector 14HQ721G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
| 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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3
Image /page/3/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.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
Jan 25, 2023
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • Name of Sponsor: | LG Electronics Inc. |
|---|---|
| - Address: | 222, LG-ro, Pyeongtaek-si, Gyeonggi-do, 17709, |
| Republic of Korea | |
| • Name of Manufacturer: | LG Electronics Inc. |
| - Address: | 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do, 39368, |
| Republic of Korea | |
| • Contact Name: | Daseul An / Regulatory Affairs Associate |
| - 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/Device/Model Name | 14HQ721G-B |
|---|---|
| Common Name | Flat Panel Digital X-ray Detector |
| Device Classification Name | Stationary X-ray System |
| Regulation Number | 21 CFR 892.1680 |
| Classification Product Code | MQB |
| Device Class | II |
| 510(k) Review Panel | Radiology |
4
Image /page/4/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 follows;
Predicate Device
- 510(k) Number: ● K221394
- Applicant: ● LG Electronics Inc.
- Trade/Device Name: 14HQ701G-B
- Common Name: Flat Panel Digital X-ray Detector
- Classification Name: Stationary X-ray System
- Regulation Number: 21 CFR 892.1680
- Classification Product MQB Code ● Device Class: ll
- 510(k) Review Panel: Radiology
The predicate devices have not been subject to a design-related recall.
5
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.
5. Description of the Device [21 CFR 807.92(a)(4)]
This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp highdefinition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device. This device must be used in conjunction with an operating PC and an X-ray qenerator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection. This device does not have a dynamic exposure feature.
14HQ721G-B is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography or dental applications. We understand the Agency has become aware of situations where solid state detectors inserted into radiographic systems adversely impacted device performance due to improper integration.
Below is a summary of the information from the 14HQ721G-B user manuals covering key electromechanical and computer requirements needed for X-ray system interface and integration.
-
- Mechanical interface requirements.
- Computer requirements 2.
-
- Data communication interface requirements
-
- Electrical power requirements
- ഗ് X-ray trigger interface requirements
Neither the 14HQ721G-B nor its software acts as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements.
The built-in AEC (Automatic Exposure Control) in 14HQ721G-B is sensors which convert the amount of the X-ray emitted from the X-ray generator into the electric signals and deliver them to the X-ray generator connected with the X-ray detector via the control box. The X-ray generator determines for
6
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 logo is simple and modern, and the colors are eye-catching.
itself whether to stop x-ray emission based on these electrical signals. The 14HQ721G-B does not directly control the X-ray generator.
6. Indications for use [21 CFR 807.92(a)(5)]
The Flat Panel Digital X-ray Detector 14HQ721G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
7. Intended Use [21 CFR 807.92(a)(5)]
The Flat Panel Digital X-ray Detector 14HQ721G-B is a prescription device, and it is not intended to be used for mammography.
- The detector is indicated for digital imaging solution designed for general radiographic system for human anatomy
- The detector is indicated to replace film or screen based radiographic systems in all general purpose diagnostic procedures.
7
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 logo is simple and modern, and the colors are eye-catching.
8. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
There are no significant differences in the technological characteristics of the proposed device compared to the predicate device which would adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the 14HQ721G-B and the predicate device:
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| K Number | K223546 | K221394 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Same |
| Trade Name | 14HQ721G-B | 14HQ701G-B | - |
| Common Name | Flat Panel Digital X-ray Detector | Flat Panel Digital X-ray Detector | Same |
| Product Code | MQB | MQB | Same |
| Regulation | |||
| Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| 510(k) Review | |||
| Panel | Radiology | Radiology | Same |
| Indications for | |||
| Use | The Flat Panel Digital X-ray Detector | ||
| 14HQ721G-B is indicated for digital | |||
| imaging solution designed for | |||
| general radiographic system for | |||
| human anatomy. It is intended to | |||
| replace film or screen based | |||
| radiographic systems in all general | |||
| purpose diagnostic procedures. Not | |||
| to be used for mammography. | The Flat Panel Digital X-ray Detector | ||
| 14HQ701G-B is indicated for digital | |||
| imaging solution designed for | |||
| general radiographic system for | |||
| human anatomy. It is intended to | |||
| replace film or screen based | |||
| radiographic systems in all general | |||
| purpose diagnostic procedures. Not | |||
| to be used for mammography. | Same | ||
| Intended use | The Flat Panel Digital X-ray Detector | ||
| 14HQ721G-B is a prescription | |||
| device, and it is not intended to be | |||
| used for mammography. |
- The detector is indicated for
digital imaging solution
designed for general
radiographic system for
human anatomy - The detector is indicated to
replace film or screen based
radiographic systems in all
general purpose diagnostic
procedures. | The Flat Panel Digital X-ray Detector
14HQ701G-B is a prescription
device, and it is not intended to be
used for mammography. - The detector is indicated for
digital imaging solution
designed for general
radiographic system for
human anatomy - The detector is indicated to
replace film or screen based
radiographic systems in all
general purpose diagnostic
procedures. | Same |
| Detector | | | |
| Scintillator | Csl | Csl | Same |
| Imaging Area | 14 x 17 inches | 14 x 17 inches | Same |
| Pixel Matrix | 2.500 x 3.052 pixels | 2.500 x 3.052 pixels | Same |
| [Table 1, Comparison of Proposed Device to Predicate Device] | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------------------- | -- |
8
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 logo is simple and modern, and it is easily recognizable.
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| Pixel Pitch | 140 um | 140 um | Same |
| High Contrast | |||
| Limiting | |||
| Resolution | |||
| (LP/mm) | 3.6 lp/mm | 3.6 lp/mm | Same |
| Communication | Wired/Wireless | Wired/Wireless | Same |
| DQE | Typ.66% @0.1lp/mm | Typ.66% @0.1lp/mm | Equivalent |
| MTF | Typ.84% @0.5lp/mm | Typ.84% @0.5lp/mm | Equivalent |
| Resolution | 3.6lp | 3.6lp | Same |
| Anatomical | |||
| Sites | General | General | Same |
| Exposure Mode | Manual, Auto (AED) | Manual, Auto (AED) | Same |
| Built-in AEC | O | X | Different |
| Semi Dynamic | |||
| mode | O | O | Same |
| Wireless | Standard: | ||
| 802.11 a/b/g/n/ac compliance | |||
| Frequency: 2.4 GHz/5GHz | |||
| Bandwidth: 20MHz/40MHz/80MHz | |||
| MIMO: 2x2 | Standard: | ||
| 802.11 a/b/g/n/ac compliance | |||
| Frequency: 2.4 GHz/5GHz | |||
| Bandwidth: 20MHz/40MHz/80MHz | |||
| MIMO: 2x2 | Same | ||
| Rating | 24V --- 2.1A | 24V --- 2.1A | Same |
| Gap Analysis | The difference from the predicate device (14HQ701G-B) is the addition of the built-in | ||
| AEC mode and the software update, which would not adversely affect the safety and | |||
| the effectiveness of the product. The software update includes the addition of the AEC | |||
| mode. | |||
| The proposed device (14HQ721G-B) has shown similar performance (DQE, MTF) as the | |||
| predicate device. Therefore, the proposed device is substantially equivalent to the | |||
| predicate device. |
** Semi Dynamic mode is a function that can transmit five images per second to the PC.
There are no significant differences between the 14HQ721G-B and the predicate device that would adversely affect the use of the product. It is concluded that the 14HQ721G-B is substantially equivalent to the predicate devices in design, function, materials, operational principles and intended use. The electrical safety test, EMC test and the performance test were conducted on the proposed devices, and the software was validated.
In this submission, clinical testing was not conducted, since nonclinical information is sufficient to show the substantial equivalence of the proposed devices to the predicate devices for the modifications.
9
Image /page/9/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.
9. Non-Clinical Test summary
The 14HQ721G-B complies with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
1 ) Electrical Safety, Electromagnetic Compatibility and Performance:
The 14HQ721G-B complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------|
| ES60601-
1 | AAMI | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance (IEC 60601-1:2005, MOD)
[Including Amendment 2 (2021)] | ES60601-1:
2005(R)2012
& A1:2012
[Incl.
AMD2:2021] | 2021 |
| 60601-1-
2 | IEC | Medical Electrical Equipment - Part 1-2:
General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility -
Requirements and Tests | 60601-1-2
Edition 4.0
2014-02 | 2014 |
| - | FDA | Radio Frequency Wireless Technology in
Medical Devices | August 14 | 2013 |
| - | FDA | Guidance for the Submission of 510(k)s for
Solid State X-ray Imaging Devices | September 1 | 2016 |
2) Software Validation
The 14HQ721G-B includes the software of MODERATE level of concern as a firmware. The difference from the predicate device is the addition of the AEC mode. The software was designed and developed according to the internal software development process and was verified and validated. 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) Biocompatibility
- . ISO 10993-1 and series, Biological evaluation of medical devices
4) Performance Test
Imaging performance test was conducted according to:
510(k) Summary
10
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 logo is simple and modern, and it is easily recognizable.
- IEC 62220-1-1, Medical Electrical Equipment Characteristics of Digital X-ray Imaging Devices ● Part 1-1: Determination of the Detective Quantum Efficiency – Detectors Used in Radiographic Imaging.
5) Cybersecurity
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October 18, 2018
- Postmarket Management of Cybersecurity in Medical Devices, on December 28, 2016
6) Label
- CFR Part 801
- Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, 2017
10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between 14HQ721G-B and the predicate device, K221394 that would adversely affect the use of the product. The proposed device is substantially equivalent to the predicate device in indications for use and technology characteristics.
11. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food & Druq and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification of LG Electronics, it is concluded that the 14HQ721G-B is substantially equivalent in safety and effectiveness to the predicate device as described herein.