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.

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Flat Panel Digital X-ray Detector (14HQ701G-B) and its substantial equivalence to a predicate device (14HK701G-W). However, the document does not contain the specific details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested.

The document discusses:

Non-Clinical Test Summary: This section lists compliance with electrical safety, EMC, software validation, biocompatibility, performance tests (including IEC 62220-1 for DQE), and cybersecurity.
Clinical Test Summary: It states, "Clinical data has been provided according to FDA guidance 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."

This phrasing indicates that clinical data was submitted to support the device's functionality, but the core of the substantial equivalence claim relies on non-clinical performance and technological characteristics, not a detailed clinical study with specific acceptance criteria that would typically be associated with AI/CAD devices. The device described is a digital X-ray detector, which is hardware, not an AI or CAD system. Thus, many of the requested points regarding AI/CAD studies (e.g., human readers, effect size of AI assistance, training set details) are not applicable to the information provided.

Therefore,Based on the provided text, the device is a Flat Panel Digital X-ray Detector, not an AI-powered diagnostic tool. As such, many of the requested details regarding acceptance criteria for AI performance and associated studies (e.g., human reader improvement, training sets, ground truth establishment methods typical for AI) are not present in this 510(k) summary.

The document mainly focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance, electrical safety, EMC, software validation, and biocompatibility, as well as general clinical data to show it works as intended.

Here's an attempt to answer the questions based only on the information provided, indicating where information is not available or not applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (from predicate comparison)	Reported Device Performance (14HQ701G-B)
Technological Characteristics
Scintillator	CsI	CsI
Imaging Area	13.7 x 16.8 inches (Predicate)	14 x 17 inches
Pixel Matrix	2,500 x 3,052 pixels	2,500 x 3,052 pixels
Pixel Pitch	140 um	140 um
High Contrast Limiting Resolution (LP/mm)	3.6 lp/mm	3.6 lp/mm
Communication	Wired/Wireless	Wired/Wireless
DQE @0.1lp/mm	Typ. 72% (Predicate)	Typ. 66%
MTF @0.5lp/mm	Typ. 89% (Predicate)	Typ. 84%
Resolution	3.6lp	3.6lp
Anatomical Sites	General	General
Exposure Mode	Manual, Auto (AED)	Manual, Auto (AED)
Semi Dynamic mode	O (Yes)	O (Yes)
Wireless Standard	802.11 a/b/g/n/ac compliance; 2.4/5 GHz; 20/40/80 MHz B/W; 2x2 MIMO	802.11 a/b/g/n/ac compliance; 2.4/5 GHz; 20/40/80 MHz B/W; 2x2 MIMO
Rating	24V --- 2.1A	24V --- 2.1A
Non-Clinical Performance
Electrical Safety	Compliance with ES60601-1	Complied
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Complied
Software Validation	Designed/developed per software development process; verified/validated (MODERATE level of concern)	Verified and Validated
Biocompatibility	Compliance with ISO 10993-1 and series	Complied
Imaging Performance	Compliance with IEC 62220-1 (DQE)	Complied
Cybersecurity	Compliance with FDA guidances	Complied

Note on Differences: The document explicitly states: "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."

2. Sample size used for the test set and the data provenance

The document mentions "clinical data has been provided," but it does not specify the sample size for this clinical data or its provenance (e.g., country of origin, retrospective/prospective). It also states this data "was not necessary to establish substantial equivalence" for the modifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. The document does not describe a ground truth establishment process involving experts in detail, nor does it specify the number or qualifications of experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No adjudication method is described.

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

Not applicable. The device is a digital X-ray detector, not an AI or CAD system designed to assist human readers. Therefore, an MRMC study comparing human readers with/without AI assistance was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a hardware component (X-ray detector), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided in detail for clinical data. For the "Imaging performance test," compliance with IEC 62220-1 (determination of DQE) implies a technical, quantitative assessment rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. The device is a hardware X-ray detector, not a machine learning model that requires a training set of images.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

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:Address:	LG Electronics Inc.77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,Republic of Korea
●	Name of Manufacturer:Address:	LG Electronics Inc.77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,Republic of Korea
●	Contact Name:Telephone No.:Email Address:	Jinhwan Jun / Chief Research Engineer+82-31-8066-5641jinhwan.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 ProductCode	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)]

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.
1. Computer requirements
1. Data communication interface requirements
1. Electrical power requirements

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)]

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
RegulationNumber	21 CFR 892.1680	21 CFR 892.1680	Same
510(k) ReviewPanel	Radiology	Radiology	Same
Indications forUse	The Flat Panel Digital X-ray Detector14HQ701G-B is indicated for digitalimaging solution designed for generalradiographic system for humananatomy. It is intended to replacefilm or screen based radiographicsystems in all general purposediagnostic procedures. Not to beused for mammography.	Flat Panel Digital X-ray Detectors areindicated for digital imaging solutiondesigned for general radiographicsystem for human anatomy. It isintended to replace film or screenbased radiographic systems ingeneral purpose diagnosticprocedures all and not to be used formammography.	Same
Intended use	The Flat Panel Digital X-ray Detector14HQ701G-B is a prescription device,and it is not intended to be used formammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures.	The Flat Panel Digital X-ray Detector14HK701G-W is a prescription device,and it is not intended to be used formammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures.	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 ContrastLimitingResolution(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 Dynamicmode	O	O	Same
Wireless	Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 2x2	Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 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:

Electrical Safety, Electromagnetic Compatibility and Performance:

The 14HQ701G-B comply with the electrical safety and electromagnetic compatibility requirements established by the standards.

StandardsNo.	StandardsOrganization	Standard Title	Version	PublicationYear
ES60601-1	AAMI	Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance (IEC 60601-1:2005, MOD)	ES60601-1:2005(R)2012 andA1:2012	2014
60601-1-2	IEC	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Safety – Collateral Standard:Electromagnetic Compatibility - Requirementsand Tests	60601-1-2Edition 4.02014-02	2016
-	FDA	Radio Frequency Wireless Technology in MedicalDevices	August 14	2013
-	FDA	Guidance for the Submission of 510(k)s for SolidState 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.

Regulation Number and Section

§ 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.