14HQ701G-B
Device Facts
| Record ID | K221394 |
|---|---|
| Device Name | 14HQ701G-B |
| Applicant | Lg Electronics.Inc |
| Product Code | MQB · Radiology |
| Decision Date | Jul 22, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
14HQ701G-B is a flat panel digital X-ray detector using amorphous silicon and a high-performance scintillator to acquire and process digital X-ray images. It functions as an image acquisition component within a larger system, requiring integration with an external X-ray generator and an operating PC. The device captures X-ray signals and transmits them via wired or wireless connection to the PC for radiological diagnosis. It supports manual and automatic (AED) exposure modes and a semi-dynamic mode (5 images/sec). Used in clinical settings by healthcare professionals, the output is displayed on a workstation for diagnostic review. The device does not control the X-ray generator. It benefits patients by providing high-definition digital imaging (3.6 lp/mm resolution) to replace traditional film/screen systems, facilitating faster image processing and transfer.
Clinical Evidence
Clinical data was provided as supplemental evidence to demonstrate the device works as intended, though not required to establish substantial equivalence. No specific clinical study metrics (e.g., sensitivity, specificity) were reported in the summary.
Technological Characteristics
Flat panel detector using amorphous silicon and CsI scintillator. Resolution: 3.6 lp/mm; Pixel pitch: 140 um. Connectivity: Wired/Wireless (802.11 a/b/g/n/ac, 2.4/5GHz, 2x2 MIMO). Power: 24V/2.1A. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62220-1. Software: Moderate level of concern firmware.
Indications for Use
Indicated for digital imaging in general radiographic systems for human anatomy; intended to replace film or screen-based systems in general-purpose diagnostic procedures. Not for mammography or dental applications.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- 14HK701G-W (K182348)
Submission Summary (Full Text)
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July 22, 2022
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LG Electronics, Inc. % Woo Chai Kyoung Senior consultant GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 REPUBLIC OF KOREA
Re: K221394
Trade/Device Name: 14HQ701G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: May 10, 2022 Received: May 17, 2022
Dear Woo Chai Kyoung:
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
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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 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 (OS) 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,
Laurel Burk, 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
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# Indications for Use
510(k) Number (if known) K221394
Device Name 14HQ701G-B
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Prescription Use (Part 21 CFR 201 Subpart D) | <svg height="12" width="12"> <rect fill="black" height="12" width="12"></rect> </svg> |
| Over-The-Counter Use (21 CFR 201 Subpart C) | <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" width="12"></rect> </svg> |
> 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)]
May 10, 2022
#### 2. Submitter's Information [21 CFR 807.92(a)(1)]
| ● | Name of Sponsor:<br>Address: | LG Electronics Inc.<br>77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,<br>Republic of Korea |
|---|---------------------------------------------------|------------------------------------------------------------------------------------------------|
| ● | Name of Manufacturer:<br>Address: | LG Electronics Inc.<br>77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,<br>Republic of Korea |
| ● | Contact Name:<br>Telephone No.:<br>Email Address: | Jinhwan Jun / Chief Research Engineer<br>+82-31-8066-5641<br>jinhwan.jun@lge.com |
## 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device/Model Name | 14HQ701G-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 |
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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: | K182348 |
|---|--------------------------------|-----------------------------------|
| ● | Applicant: | LG Electronics Inc. |
| ● | Trade/Device Name: | 14HK701G-W |
| ● | Common Name: | Flat Panel Digital X-ray Detector |
| ● | Classification Name: | Stationary X-ray System |
| ● | Regulation Number: | 21 CFR 892.1680 |
| ● | Classification Product<br>Code | MQB |
| ● | Device Class: | II |
| ● | 510(k) Review Panel: | Radiology |
The predicate devices have not been subject to a design-related recall
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#### 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 high-definition 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 generator. 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.
14HQ701G-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 (reference:
http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM385149.pdf).
Below is a summary of the information from the 14HQ701G-B user manuals covering key electromechanical and computer requirements needed for X-ray system interface and integration.
- 1. Mechanical interface requirements.
- 2. Computer requirements
- 3. Data communication interface requirements
- 4. Electrical power requirements
5. X-ray trigger interface requirements Neither the 14HQ701G-B nor its software act as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements.
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## 6. Indications for use [21 CFR 807.92(a)(5)]
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.
# 7. Intended Use [21 CFR 807.92(a)(5)]
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.
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## 8. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
There are no significant differences in the technological characteristics of these devices compared to the predicate devices which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the 14HQ701G-B and the predicate devices:
| | Proposed Device | Predicate Device | Note |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| K Number | TBD | K182348 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Same |
| Trade Name | 14HQ701G-B | 14HK701G-W | - |
| Common Name | Flat Panel Digital X-ray Detector | Flat Panel Digital X-ray Detector | Same |
| Product Code | MQB | MQB | Same |
| Regulation<br>Number | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| 510(k) Review<br>Panel | Radiology | Radiology | Same |
| Indications for<br>Use | The Flat Panel Digital X-ray Detector<br>14HQ701G-B is indicated for digital<br>imaging solution designed for general<br>radiographic system for human<br>anatomy. It is intended to replace<br>film or screen based radiographic<br>systems in all general purpose<br>diagnostic procedures. Not to be<br>used for mammography. | Flat Panel Digital X-ray Detectors are<br>indicated for digital imaging solution<br>designed for general radiographic<br>system for human anatomy. It is<br>intended to replace film or screen<br>based radiographic systems in<br>general purpose diagnostic<br>procedures all and not to be used for<br>mammography. | Same |
| Intended use | The Flat Panel Digital X-ray Detector<br>14HQ701G-B is a prescription device,<br>and it is not intended to be used for<br>mammography.<br>- The detector is indicated for<br>digital imaging solution<br>designed for general<br>radiographic system for<br>human anatomy<br>- The detector is indicated to<br>replace film or screen based<br>radiographic systems in all<br>general purpose diagnostic<br>procedures. | The Flat Panel Digital X-ray Detector<br>14HK701G-W is a prescription device,<br>and it is not intended to be used for<br>mammography.<br>- The detector is indicated for<br>digital imaging solution<br>designed for general<br>radiographic system for<br>human anatomy<br>- The detector is indicated to<br>replace film or screen based<br>radiographic systems in all<br>general purpose diagnostic<br>procedures. | Same |
| Detector | | | |
| Scintillator | CsI | CsI | Same |
| Imaging Area | 14 x 17 inches | 13.7 x 16.8 inches | Different |
| Pixel Matrix | 2,500 x 3,052 pixels | 2,500 x 3,052 pixels | Same |
| Pixel Pitch | 140 um | 140 um | Same |
| High Contrast<br>Limiting<br>Resolution<br>(LP/mm) | 3.6 lp/mm | 3.6 lp/mm | Same |
| Communication | Wired/Wireless | Wired/Wireless | Same |
| DQE | Typ.66% @0.1lp/mm | Typ.72% @0.1lp/mm | Different |
| MTF | Typ.84% @0.5lp/mm | Typ.89% @0.5lp/mm | Different |
| | Proposed Device | Predicate Device | Note |
| Resolution | 3.6lp | 3.6lp | Same |
| Anatomical Sites | General | General | Same |
| Exposure Mode | Manual, Auto (AED) | Manual, Auto (AED) | Same |
| Semi Dynamic<br>mode | O | O | Same |
| Wireless | Standard:<br>802.11 a/b/g/n/ac compliance<br>Frequency: 2.4 GHz/5GHz<br>Bandwidth: 20MHz/40MHz/80MHz<br>MIMO: 2x2 | Standard:<br>802.11 a/b/g/n/ac compliance<br>Frequency: 2.4 GHz/5GHz<br>Bandwidth: 20MHz/40MHz/80MHz<br>MIMO: 2x2 | Same |
| Rating | 24V --- 2.1A | 24V --- 2.1A | Same |
| Gap Analysis | There is minor difference in the 'Imaging Area', 'DQE', and 'MTF'. The minor differences between the subject and predicate device do not affect a decision of substantial equivalence. So Proposed device (14HQ701G-B) and Predicate Device (14HK701G-W) are substantially same. | | |
[Table 1. Comparison of Proposed Device to Predicate Device]
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** Semi Dynamic mode is a function that can transmit five images per second to the PC.
There are no significant differences between the 14HQ701G-B and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use. The proposed device, 14HQ701G-B has been tested about electrical safety, EMC and performance, and the software has been validated. In addition, the clinical data has been provided to support the substantial equivalence to the predicate devices.
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#### 9. Non-Clinical Test summary
The 14HQ701G-B comply 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 14HQ701G-B comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
| Standards<br>No. | Standards<br>Organization | Standard Title | Version | Publication<br>Year |
|------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------|
| ES60601-1 | AAMI | Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (IEC 60601-1:2005, MOD) | ES60601-1:<br>2005(R)201<br>2 and<br>A1:2012 | 2014 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2: General<br>Requirements for Safety – Collateral Standard:<br>Electromagnetic Compatibility - Requirements<br>and Tests | 60601-1-2<br>Edition 4.0<br>2014-02 | 2016 |
| - | FDA | Radio Frequency Wireless Technology in Medical<br>Devices | August 14 | 2013 |
| - | FDA | Guidance for the Submission of 510(k)s for Solid<br>State X-ray Imaging Devices | September 1 | 2016 |
#### 2) Software Validation
The 14HQ701G-B contains MODERATE level of concern software as firmware. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:
- . 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 has been conducted according to:
- IEC 62220-1, 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
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#### 6) Label
- CFR Part 801
- Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, 2017 ●
#### 10. Clinical Test Summary
Clinical data has been provided according to FDA quidance document "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices". The data was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended.
#### 11. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between 14HQ701G-B and the predicate device, K182348 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.
#### 12. 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 14HQ701G-B is substantially equivalent in safety and effectiveness to the predicate device as described herein.
