17HK700G-W

K180332 · Lg Electronics · MQB · Jun 8, 2018 · Radiology

Device Facts

• Record ID: K180332
• Device Name: 17HK700G-W
• Applicant: Lg Electronics
• Product Code: MQB · Radiology
• Decision Date: Jun 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The Flat Panel Digital X-ray Detector 17HK700G-W 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 Story

17HK700G-W is a solid-state flat panel X-ray detector; intercepts X-ray photons using a CsI:TI scintillator; converts X-rays to visible light, then to electrical signals via photo-detector array; converts signals to digital values. Used in general radiographic systems; excludes fluoroscopic, angiographic, and mammographic applications. Operated by qualified clinicians/technicians in clinical settings. Output displayed on monitors for diagnostic review; assists healthcare providers in visualizing human anatomy for clinical decision-making. Benefits include transition from film/screen to digital imaging, enabling faster image acquisition and processing.

Clinical Evidence

Clinical data provided as supplemental evidence to laboratory performance testing. No clinical data was necessary to establish substantial equivalence. Bench testing included electrical safety (AAMI ES60601-1), EMC (IEC 60601-1-2), and imaging performance (IEC 62220-1) for DQE.

Technological Characteristics

Solid-state X-ray imager; CsI:TI scintillator; 17x17 inch imaging area; 3,072 x 3,072 pixel matrix; 140 µm pixel pitch; 3.6 LP/mm resolution. Wired communication. Power: 100-240V, 50/60Hz. Exposure modes: Manual, Auto (AED). Software: Moderate level of concern. Standards: AAMI ES60601-1, IEC 60601-1-2, IEC 62220-1.

Indications for Use

Indicated for digital imaging in general radiographic systems for human anatomy; intended to replace film/screen-based systems for general diagnostic procedures. Contraindicated for mammography.

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

• S4343-W (of GC85A) (K150165)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

LG Electronics % Jinhwan Jun Chief Research Engineer 222, Lg-ro, Cheongho-ri Jinwi-myeon Pyeongtaek-si, Gyeonggi-do 17709 SOUTH KOREA

June 8th, 2018

## Re: K180332

Trade/Device Name: 17HK700G-W Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 11, 2018 Received: May 16, 2018

Dear Jinhwan Jun:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Bodge

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K180332

Device Name 17HK700G-W

Indications for Use (Describe)

The Flat Panel Digital X-ray Detector 17HK700G-W 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face within a circle and the text "LG Life's Good" to the right. The face is formed by the letters "L" and "G", and the circle is a deep red color. The text "LG Life's Good" is in a dark gray color.

# 510(k) Summary

[As Required by 21 CFR 807.92]

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

January 31, 2018

#### 2. Submitter's Information [21 CFR 807.92(a)(1)]

| • | Name of Sponsor:<br>- Address: | LG Electronics<br>222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si,<br>Gyeonggi-do, Republic of Korea |
|---|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| • | Contact Name:<br>- Telephone No.:<br>- Email Address: | Jinhwan Jun / Chief Research Engineer<br>[phone]<br>[e-mail] |
| • | Name of Manufacturer:<br>- Address: | Same as sponsor<br>Same as sponsor |

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

| Trade Name | 17HK700G-W |
|-----------------------------|-----------------------------------|
| Common Name | Flat Panel Digital X-ray Detector |
| Device Classification Name | Solid State X-Ray Imager |
| Regulation Number | 21 CFR 892.1680 |
| Classification Product Code | MQB |
| Device Class | II |
| 510k Review Panel | Radiology |

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Image /page/4/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face inside a circle and the company's slogan, "Life's Good." The face is formed by the letters "L" and "G," with the "L" serving as the nose and the "G" forming the outline of the face. The color scheme is primarily red and gray.

## 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: | K150165 |
|--------------------------------|---------------------------------|
| • Applicant: | Samsung Electronics Co., Ltd. |
| • Trade Name: | S4343-W (of GC85A) |
| • Common Name: | Digital Diagnostic X-ray System |
| • Classification Name: | Stationary System, X-ray |
| • Regulation Number: | 21 CFR 892.1680 |
| • Classification Product Code: | KPR |
| • Device Class: | II |
| • 510(k) Review Panel: | Radiology |

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

The 17HK700G-W is the solid state x-ray imager, which can generate radiographic images of any part of the body. These devices intercept x-ray photons and the scintillator (CsI:TI) emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images are displayed on monitors. The digital value can be communicated to the operator console via wiring connection.

The 17HK700G-W consists of the following components: Flat Panel Detector, Control Box, Calibration Software and power cord and cables. The 17HK700G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications.

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

The Flat Panel Digital X-ray Detector 17HK700G-W 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.

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Image /page/5/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized face formed by the letters 'L' and 'G' inside a circle, and the text 'LG Life's Good' to the right. The face is in a shade of red, while the letters 'LG' and the slogan 'Life's Good' are in a dark gray color. The logo is simple, modern, and recognizable, reflecting the company's brand identity.

#### 7. 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 17HK700G-W and the predicate devices:

| | Proposed Device | Predicate Device |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Not known | K150165 |
| Manufacturer | LG Electronics | Samsung Electronics Co., Ltd. |
| Trade Name | 17HK700G-W | S4343-W (of GC85A) |
| Common Name | Flat Panel Digital X-ray Detector | Digital Diagnostic X-ray System |
| Product Code | MQB | KPR |
| Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 510(k) Review<br>Panel | Radiology | Radiology |
| Indications for Use | The Flat Panel Digital X-ray<br>Detector 17HK700G-W is indicated<br>for digital imaging solution designed<br>for general radiographic system for<br>human anatomy. It is intended to<br>replace film or screen based<br>radiographic systems in all general<br>purpose diagnostic procedures. Not<br>to be used for mammography. | The GC85A Digital X-ray Imaging<br>System is intended for use in<br>generating radiographic images of<br>human anatomy by a qualified/trained<br>doctor or technician. This device is not<br>intended for mammographic<br>applications. |
| Detector | | |
| Scintillator | CsI | CsI |
| Imaging Area | 17 x 17 inches | 17 x 17 inches |
| Pixel Matrix | 3,072 x 3,072 pixels | 3,036 x 3,040 pixels |
| Pixel Pitch | 140 um | 140 µm |
| High Contrast<br>Limiting Resolution<br>(LP/mm) | 3.6 | 3.57 |
| Communication | Wired | Wired/Wireless |
| DQE | Typ.72% @0.1lp/mm | Typ.73% @0.1lp/mm |
| MTF | Typ.89% @0.5lp/mm | Typ.84% @0.5lp/mm |
| Resolution | 3.6lp | 3.57lp |
| Anatomical Sites | General | General |
| Exposure Mode | Manual, Auto(AED) | Manual, Auto(AED) |
| Power Supply | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz |

There are no significant differences between the 17HK700G-W 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, 17HK700G-W 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 device.

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Image /page/6/Picture/0 description: The image shows the logo for LG. The logo consists of two parts: a stylized face inside a circle on the left and the letters "LG" in gray on the right. Below the letters "LG" are the words "Life's Good" in a smaller font.

The predicate device is the X-ray system but the proposed device provides only a detector. The proposed device is substantially equivalent to the previously cleared detector which is provided as part of the complete imaging system, K150165.

#### 8. Integration Specifications/Requirements for 17HK700G-W

| No. | Item | Specification |
|-----|-----------------|--------------------------------|
| 1 | Power frequency | 50Hz ~ 60Hz |
| 2 | KV | 40kVp ~ 150kVp |
| 3 | mA Range | 10 to 500mA |
| 4 | Exposure Time | 0.001 to 10sec |
| 5 | mAs Range | 0.1 to 500mAs |
| 6 | Accuracy | kV < ±(1%+1kV), mA < ±(3%+1mA) |

The proposed device is provided with the recommended generator specification as follows:

## 9. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

| | | | 1) Electrical Safety and Electromagnetic Compatibility |
|--|--|--|---------------------------------------------------------|
| | | | |

| Standards<br>No. | Standards<br>Organization | Standard Title | Version | Publication<br>Year |
|------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------|
| ES60601-1 | AAMI | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD) | ES60601-1:<br>2005(R)2012 and<br>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<br>Edition 4.0<br>2014-02 | 2016 |

#### 2) Software Validation

The 17HK700G-W contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.

The software information is provided in accordance with FDA quidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.

#### 3) 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.

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Image /page/7/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face inside a circle and the letters "LG" in a bold, sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller, italicized font. The face and circle are in a shade of red, while the letters and slogan are in gray.

#### 10. Clinical Test Summary [ 21 CFR 807.92(b)(2)]

Clinical data has been provided according to FDA quidance document "Guidance for the Submission of 510(k)s for Solid Sate 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 17HK700G-W and the predicate devices, K150165 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 17HK700G-W is substantially equivalent in safety and effectiveness to the predicate devices as described herein.