(11 days)
No
The document describes a standard digital X-ray detector and its components. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies. The software is described as having a Moderate level of concern and being identical to the predicate software, further indicating a lack of novel AI/ML features.
No.
This device is an X-ray detector used for diagnostic imaging, not for treating a disease or condition.
Yes
The device is an X-ray detector used to create radiographic images for "general purpose diagnostic procedures," indicating its role in the diagnostic process.
No
The device description explicitly lists hardware components such as a Flat Panel Detector, Control Box, battery Charger, batteries, power adapter, power cord, and cables. While it mentions supporting software, it is not solely a software device.
Based on the provided text, 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 body, not a test performed on samples taken from the body.
- Device Description: The description details how the device captures X-ray photons and converts them into digital images of the body. This is consistent with an in-vivo imaging device.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information about a patient's health status based on laboratory testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to create images of the internal structure of the body directly.
N/A
Intended Use / Indications for Use
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.
Product codes
MQB
Device Description
The 17HK701G-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 17HK701G-W consists of the following components: Flat Panel Detector, Control Box, battery Charger, 2 packs of battery, power adapter for charger, Calibration Software, power cord and cables. The 17HK701G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications. The subject device is supported by software. The software is of Moderate level of concern and is identical to the predicate software.
Mentions image processing
Not Found
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:
The 17HK701G-W 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 17HK701G-W comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Software Validation: The 17HK701G-W 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
- Performance Test: Imaging performance test has been conducted according to IEC 62220-1.
- Cybersecurity
- Label
Clinical Test Summary:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- High Contrast Limiting Resolution (LP/mm): 3.6 lp/mm
- DQE: Typ.72% @0.1lp/mm
- MTF: Typ.89% @0.5lp/mm
- Resolution: 3.6lp
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
LG Electronics Inc. Jinhwan Jun Chief Research Engineer 22, LG-Ro Jinwi-Myeon Pyeongtaek-Si 17709 Gyeonggi-do, KOREA December 7, 2018
Re: K183286
Trade/Device Name: 17HK701G-W Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: November 20, 2018 Received: November 26, 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 Mav 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | Expiration Date: January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K183286 |
| Device Name | 17HK701G-W |
| Indications for Use (Describe) | 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. | |
| 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." |
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510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
Nov. 12, 2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • | Name of Manufacturer: | LG Electronics Inc. |
|---|---|---|
| • | Address: | 77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381 |
| Republic of Korea | ||
| • | Contact Name: | Jinhwan Jun / Chief Research Engineer |
| • | Telephone No.: | +82-31-8066-5641 |
| • | Email Address: | Jinhwan.jun@lge.com |
| • | Registration No.: | 3013501671 |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device Name | 17HK701G-W |
|---|---|
| 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: | 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)]
The 17HK701G-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 17HK701G-W consists of the following components: Flat Panel Detector, Control Box, battery Charger, 2 packs of battery, power adapter for charger, Calibration Software, power cord and cables. The 17HK701G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications. The subject device is supported by software. The software is of Moderate level of concern and is identical to the predicate software.
6
6. Indications for use [21 CFR 807.92(a)(5)]
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.
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 17HK701G-W and the predicate devices:
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| K Number | Not known | K182348 | |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Same |
| Trade Name | 17HK701G-W | 14HK701G-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 | 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. | Flat Panel Digital X-ray Detector 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 | ||
| Detector | |||
| Scintillator | CsI | CsI | Same |
| Imaging Area | 17 x 17 inches | 13.7 x 16.8 inches | Different |
| Pixel Matrix | 3,060 x 3,060 pixels | 2,488 x 3,040 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 | Different |
| DQE | Typ.72% @0.1lp/mm | Typ.72% @0.1lp/mm | Same |
| MTF | Typ.89% @0.5lp/mm | Typ.89% @0.5lp/mm | Same |
| Resolution | 3.6lp | 3.6lp | Same |
| Anatomical Sites | General | General | Same |
| Exposure Mode | Manual, Auto(AED) | Manual, Auto(AED) | Same |
| Wireless | Standard: | - |
[Table 1. Comparison of Proposed Device to Predicate Device]
7
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| 802.11 a/b/g/n/ac compliance | |||
| Frequency: 2.4 GHz/5GHz | |||
| Bandwidth: 20MHz/40MHz/80MHz | |||
| MIMO: 2x2 | |||
| Rating | 24V --- 2.1A | 24V --- 2.1A | Same |
| Gap Analysis | There is some difference in the 'Imaging Area' and 'Pixel matrix'. But This functions | ||
| are not related to the 'safety' and 'performance' of the device. So Proposed device | |||
| (17HK701G-W) and Predicate Device (14HK701G-W) are substantially same. |
There are no significant differences between the 17HK701G-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, 17HK701G-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 devices.
The technological characteristics of the subject detector 17HK701G-W are similar to the predicate 14HK701G-W, and the only major difference is the larger detector size
8. Integration Specifications / Requirements for 17HK701G-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 4sec |
| 5 | mAs Range | 0.1 to 500mAs |
| 6 | Accuracy | kV |