(51 days)
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 device description, intended use, or performance studies. The performance studies focus on standard electrical, software, biocompatibility, imaging performance, and cybersecurity testing, not AI/ML model validation.
No
The device is described as an X-ray imaging device used for diagnostic purposes, specifically for acquiring and processing X-ray images for radiological diagnosis, not for providing therapy.
Yes
The device is an X-ray detector used for acquiring and processing X-ray images, which are then used for "radiological diagnosis", indicating its function in identifying medical conditions.
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 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 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 details 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," further reinforcing its use for imaging the body.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to capture images using X-rays, which is a different category of medical device.
N/A
Intended Use / Indications for Use
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.
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 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
General radiographic system for human anatomy.
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:
- Electrical Safety, Electromagnetic Compatibility and Performance: The 14HQ901G-B comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Software Validation: The 14HQ901G-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.
- Biocompatibility: ISO 10993-1 and series, Biological evaluation of medical devices.
- Performance Test: Imaging performance test has been conducted according to IEC 62220-1.
- Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, on October 18, 2018; Postmarket Manaqement of Cybersecurity in Medical Devices, on December 28, 2016.
- Label: CFR Part 801; Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, 2017.
Clinical Test Summary:
Clinical data has been provided according to FDA guidance 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.
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
February 16, 2022
Image /page/0/Picture/1 description: The image contains 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 logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
LG Electronics Inc. % Mr. Dogyun Im Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, 03909 KOREA
Re: K214044
Trade/Device Name: 14HQ901G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 17, 2021 Received: December 27, 2021
Dear Mr. Im:
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 Assistant Director Diagnostic X-ray Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K214044
Device Name 14HQ901G-B
Indications for Use (Describe)
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.
| 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) |
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- 510(K) Summary
4
K214044
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
December 15, 2021
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 | 14HQ901G-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: | K183286 |
|---|---|---|
| ● | Applicant: | LG Electronics Inc. |
| ● | Trade/Device Name: | 17HK701G-W |
| ● | Common Name: | Digital Diagnostic X-ray System |
| ● | Classification Name: | System. X-ray, Stationary |
| ● | 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 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 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.
7. Intended Use [21 CFR 807.92(a)(5)]
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.
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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 14HQ901G-B and the predicate devices:
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| K Number | Not known | K183286 | |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Same |
| Trade Name | 14HQ901G-B | 17HK701G-W | Same |
| 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 | ||
| 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. | Flat Panel Digital X-ray Detector | ||
| 17HK701G-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 general purpose | |||
| diagnostic procedures all and not to | |||
| be used for mammography. | Same | ||
| Detector | |||
| Scintillator | CsI | CsI | Same |
| Imaging Area | 14 x 17 inches | 17 x 17 inches | Different |
| Pixel Matrix | 2,560 x 3,072 pixels | 3,060 x 3,060 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.72% @0.1lp/mm | Different |
| MTF | Typ.84% @0.5lp/mm | Typ.89% @0.5lp/mm | Different |
| Resolution | 3.6lp | 3.6lp | Same |
| Anatomical Sites | General | General | Same |
| Exposure Mode | Manual, Auto (AED) | Manual, Auto (AED) | Same |
| Semi Dynamic | |||
| mode | O | × | Different |
| 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 some difference in the 'Imaging Area,' "Pixel matrix,' 'MTF,' 'DQE' and 'semi dynamic mode.' Imaging area and pixel matrix are not related to the device's 'safety and 'performance.' And proposed device has different 'DQE' and 'MTF' compared with |
| [Table 1. Comparison of Proposed Device to Predicate Device] | ||||
|---|---|---|---|---|
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| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| the predicate device. But there are no differences in performance as a result of | |||
| performing the clinical test. Semi Dynamic mode is a function that can transmit five | |||
| images per second to the PC. But this function does not affect the safety and | |||
| performance of the subject device. So Proposed device (14HQ901G-B) and Predicate | |||
| Device (17HK701G-W) are substantially same. |
There are no significant differences between the 14HQ901G-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, 14HQ901G-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.
The technological characteristics of the subject detector 14HQ901G-B are similar to the predicate 17HK701G-W, and the only major difference is the larger detector size.
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9. Non-Clinical Test summary
The 14HQ901G-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 14HQ901G-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 14HQ901G-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 Manaqement of Cybersecurity in Medical Devices, on December 28, 2016 ●
- Label
11
- 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 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 14HQ901G-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 14HQ901G-B is substantially equivalent in safety and effectiveness to the predicate device as described herein.