(70 days)
Not Found
No
The summary describes a standard digital X-ray detector and its image acquisition and processing capabilities, but there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The device is described as an X-ray imaging device intended for diagnostic purposes (acquiring and processing X-ray images for radiological diagnosis), not for treating conditions.
Yes
The device replaces existing radiographic systems used for "general purpose diagnostic procedures" and is used to acquire and transfer "X-ray images for radiological diagnosis."
No
The device description explicitly states it is a flat panel based X-ray image acquisition device utilizing amorphous silicon and a high-performance scintillator, which are hardware components. It also mentions data transmission between the Detector and PC via wired or wireless connection, further indicating hardware.
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 a device used for capturing images of the internal structure of the body, not for testing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on its function as an "x-ray imaging device" that "acquire and process X-ray images." This aligns with diagnostic imaging, not in vitro diagnostics.
- Input Imaging Modality: The input modality is "X-ray," which is a form of medical imaging, not a method used in IVD testing.
- Anatomical Site: The anatomical site is "General radiographic system for human anatomy," indicating it's used on the human body directly.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates by capturing images of the body 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 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.
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
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
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)
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)
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
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
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 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) 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) | |
| 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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3
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
+82-31-8066-5641
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 |
4
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 | |
| 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.
-
- Mechanical interface requirements.
-
- Computer requirements
-
- Data communication interface requirements
-
- 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.
6
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 | |||
| 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 | ||
| 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. | Flat Panel Digital X-ray Detectors are | ||
| 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 | |||
| general purpose diagnostic | |||
| procedures all and not to be used for | |||
| mammography. | Same | ||
| Intended 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. | The Flat Panel Digital X-ray Detector
14HK701G-W 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 | 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
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.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
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 | 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]
8
** 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.
9
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.
| 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 |
| - | FDA | Guidance for the Submission of 510(k)s for Solid
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.