K Number
K220559
Device Name
17HQ901G-B
Date Cleared
2022-05-05

(66 days)

Product Code
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Flat Panel Digital X-ray Detector 17HQ901G-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.
More Information

Not Found

No
The summary describes a standard digital X-ray detector and its image acquisition and processing capabilities. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The software validation focuses on firmware and standard software development processes, not AI/ML model training or validation.

No
The device is an X-ray detector used for diagnostic imaging, not for treating diseases or conditions.

Yes
The device is intended to be used for "general purpose diagnostic procedures" and for "radiological diagnosis," indicating its role in identifying or characterizing diseases.

No

The device description explicitly states it is an "x-ray imaging device" that "utilizes amorphous silicon and a high-performance scintillator" and is a "flat panel based X-ray image acquisition device." These are hardware components, not software. While it includes software (firmware) for processing and data transmission, it is not solely software.

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 imaging device used on the patient, not a device used to test samples from the patient (which is the core of IVD).
  • Device Description: The description details an "x-ray imaging device" that "can acquire and process X-ray images as digital images." This further reinforces its function as an imaging system for the body.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to capture images of the internal structure of the body using X-rays.

N/A

Intended Use / Indications for Use

The Flat Panel Digital X-ray Detector 17HQ901G-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 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.

Mentions image processing

Yes

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

Not Found

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:

  1. Electrical Safety, Electromagnetic Compatibility and Performance: The 17HQ901G-B comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
  2. Software Validation: The 17HQ901G-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.
  3. Biocompatibility
  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
    Clinical Test Summary: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K214044

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

May 5, 2022

Image /page/0/Picture/1 description: The image shows 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 acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

LG Electronics Inc. % Bokyeong Kim Senior Consultant GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 REPUBLIC OF KOREA

Re: K220559

Trade/Device Name: 17HQ901G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: February 24, 2022 Received: February 28, 2022

Dear Bokyeong Kim:

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

1

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 DHT 8B: 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) K220559

Device Name 17HQ901G-B

Indications for Use (Describe)

The Flat Panel Digital X-ray Detector 17HQ901G-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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

  1. 510(K) Summary

4

510(k) Summary

[As Required by 21 CFR 807.92]

K220559

1. Date Prepared [21 CFR 807.92(a)(a)]

February 24, 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
    +82-31-8066-5641
    jinhwan.jun@lge.com |

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade/Device/Model Name17HQ901G-B
Common NameFlat Panel Digital X-ray Detector
Device Classification NameStationary X-ray System
Regulation Number21 CFR 892.1680
Classification Product CodeMQB
Device ClassII
510(k) Review PanelRadiology

5

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:K214044
Applicant:LG Electronics Inc.
Trade/Device Name:14HQ901G-B
Common Name:Digital Diagnostic X-ray System
Classification Name:System. X-ray, Stationary
Regulation Number:21 CFR 892.1680
Classification Product
CodeMQB
Device Class:II
510(k) Review Panel:Radiology

The predicate devices have not been subject to a design-related recall

6

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.

7

6. Indications for use [21 CFR 807.92(a)(5)]

The Flat Panel Digital X-ray Detector 17HQ901G-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 17HQ901G-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.

8

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 17HQ901G-B and the predicate devices:

Proposed DevicePredicate DeviceNote
K NumberK220559K214044-
ManufacturerLG Electronics Inc.LG Electronics Inc.Same
Trade Name17HQ901G-B14HQ901G-BSame
Common NameFlat Panel Digital X-ray DetectorFlat Panel Digital X-ray DetectorSame
Product CodeMQBMQBSame
Regulation
Number21 CFR 892.168021 CFR 892.1680Same
510(k) Review
PanelRadiologyRadiologySame
Indications for
UseThe Flat Panel Digital X-ray Detector
17HQ901G-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
14HQ901G-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 useThe Flat Panel Digital X-ray Detector
17HQ901G-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
    14HQ901G-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 | CsI | CsI | Same |
    | Imaging Area | 17 x 17 inches | 14 x 17 inches | Different |
    | Pixel Matrix | 3,072 x 3,072 pixels | 2,560 x 3,072 pixels | Different |
    | 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.78% @0.1lp/mm | Typ.78% @0.1lp/mm | Same |
    | MTE | Typ.84% @0.5lp/mm | Typ.84% @0.5lp/mm | Same |
[Table 1. Comparison of Proposed Device to Predicate Device]
------------------------------------------------------------------------

510(k) Summary

17HQ901G-B

9

Proposed DevicePredicate DeviceNote
Resolution3.6lp3.6lpSame
Anatomical SitesGeneralGeneralSame
Exposure ModeManual, Auto (AED)Manual, Auto (AED)Same
Semi Dynamic
modeOOSame
WirelessStandard:
802.11 a/b/g/n/ac compliance
Frequency: 2.4 GHz/5GHz
Bandwidth: 20MHz/40MHz/80MHz
MIMO: 2x2Standard:
802.11 a/b/g/n/ac compliance
Frequency: 2.4 GHz/5GHz
Bandwidth: 20MHz/40MHz/80MHz
MIMO: 2x2Same
Rating24V 2.1A24V 2.1ASame
Gap AnalysisThere is some difference in the 'Imaging Area' and 'Pixel matrix. Imaging area and
pixel matrix are not related to the device's 'safety and 'performance.' So Proposed
device (17HQ901G-B) and Predicate Device (14HQ901G-B) are substantially same.

** Semi Dynamic mode is a function that can transmit five images per second to the PC.

There are no significant differences between the 17HQ901G-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, 17HQ901G-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.

10

9. Non-Clinical Test summary

The 17HQ901G-B comply with voluntary standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

  1. Electrical Safety, Electromagnetic Compatibility and Performance:

The 17HQ901G-B comply 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) | ES60601-1:
2005(R)201
2 and
A1:2012 | 2014 |
| 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 | 2016 |
| - | FDA | Radio Frequency Wireless Technology in Medical
Devices | August 14 | 2013 |

2) Software Validation

The 17HQ901G-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 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 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

11

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 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.

11. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

There are no significant differences between 17HQ901G-B and the predicate device, K214044 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 17HQ901G-B is substantially equivalent in safety and effectiveness to the predicate device as described herein.