(50 days)
Not Found
No
The description focuses on the hardware components and basic digital conversion of X-ray signals, with no mention of AI, ML, or advanced image processing techniques that would typically indicate their use.
No
The device is described as an X-ray detector used for diagnostic imaging, which helps in identifying medical conditions rather than treating them.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for digital imaging solution designed for general radiographic system for human anatomy" and "intended to replace film or screen based radiographic systems in general purpose diagnostic procedures."
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 includes "Calibration Software" and mentions "Software Validation," the device is fundamentally a hardware system with accompanying software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Flat Panel Digital X-ray Detector" used for "digital imaging solution designed for general radiographic system for human anatomy." It directly images the human body using X-rays.
- Intended Use: The intended use is for "general purpose diagnostic procedures" by replacing film or screen-based radiographic systems. This involves imaging the internal structures of the body, not analyzing samples taken from the body.
The device is an in vivo diagnostic imaging device, meaning it is used to diagnose conditions within the living body.
N/A
Intended Use / Indications for Use
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.
Product codes
MQB
Device Description
The 14HK701G-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 14HK701G-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 14HK701G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
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
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.
Non-Clinical Test Summary:
- Electrical Safety, Electromagnetic Compatibility and Performance: The 14HK701G-W comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Software Validation: The 14HK701G-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: ISO 10993-1 and series, Biological evaluation of medical devices.
- 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.
- Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, and Postmarket Management of Cybersecurity in Medical Devices guidance documents.
Key Metrics
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
LG Electronics Inc. Jinhwan Jun Chief Research Engineer 222. LG-Ro Jinwi-Myeon, Pyeongtaek-Si, Gyeonggi-do, 17709 Korea
October 18, 2018
Re: K182348
Trade/Device Name: 14HK701G-W Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: August 22, 2018 Received: August 29, 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. 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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K182348 |
| Device Name | 14HK701G-W |
| Indications for Use (Describe) | 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. |
| 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:
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"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
- 510(K) Summary
4
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
July 20, 2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| ● | Name of Manufacturer: | LG Electronics Inc. |
|---|---|---|
| ● | Address: | 222, LG-ro, Jinwi-myeon, Pyeongtaek-si, |
| Gyeonggi-do, Republic of Korea | ||
| ● | Contact Name: | Jinhwan Jun / Chief Research Engineer |
| ● | Telephone No.: | +82-31-8066-5641 |
| ● | Email Address: | Jinhwan.jun@lge.com |
| ● | Registration No.: | 3009955829 |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device Name | 14HK701G-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 1
| ● | 510(k) Number: | K180332 |
|---|---|---|
| ● | Applicant: | LG Electronics Inc. |
| ● | Trade/Device Name: | 17HK700G-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 |
Predicate Device 2
| ● | 510(k) Number: | K150165 |
|---|---|---|
| ● | Applicant: | Samsung Electronics Co., Ltd. |
| ● | Trade/Device Name: | S4343-W (of GC85A) |
| ● | Common Name: | Digital Diagnostic X-ray System |
| ● | Classification Name: | System. X-ray, Stationary |
| ● | Regulation Number: | 21 CFR 892.1680 |
| ● | Classification Product | |
| Code | KPR | |
| ● | 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 14HK701G-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 14HK701G-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 14HK701G-W can be used for general X-ray system excluding fluoroscopic, angiographic, and mammographic applications.
7
6. Indications for use [21 CFR 807.92(a)(5)]
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 all general purpose diagnostic procedures 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 14HK701G-W and the predicate devices:
| Proposed Device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| K Number | Not known | K180332 | K150165 |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Samsung Electronics Co., |
| Ltd. | |||
| Trade Name | 14HK701G-W | 17HK700G-W | S4343-W (of GC85A) |
| Common Name | Flat Panel Digital X-ray | ||
| Detector | Flat Panel Digital X-ray | ||
| Detector | Flat Panel Digital X-ray | ||
| System | |||
| Product Code | MQB | MQB | KPR |
| Regulation | |||
| Number | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 510(k) Review | |||
| Panel | Radiology | Radiology | Radiology |
| Indications for | |||
| Use | 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. | 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. | The GC85A Digital X-ray | ||
| Imaging System is intended | |||
| for use in generating | |||
| radiographic images of | |||
| human anatomy by a | |||
| qualified/trained doctor or | |||
| technician. This device is | |||
| not intended for | |||
| mammographic | |||
| applications. | |||
| Detector | |||
| Scintillator | CsI | CsI | CsI |
| Imaging Area | 13.7 x 16.8 inches | 17 x 17 inches | 17 x 17 inches |
| Pixel Matrix | 2,500 x 3,052 pixels | 3,072 x 3,072 pixels | 3,036 x 3,040 pixels |
| Pixel Pitch | 140 um | 140 um | 140 um |
| High Contrast | |||
| Limiting | |||
| Resolution | |||
| (LP/mm) | 3.6 lp/mm | 3.6 | 3.57 |
| Communication | Wired/Wireless | Wired | Wired/Wireless |
| DQE | Typ.72% @0.1lp/mm | Typ.72% @0.1lp/mm | Typ.73% @0.1lp/mm |
| MTF | Typ.89% @0.5lp/mm | Typ.89% @ 0.5lp/mm | Typ.84% @ 0.5lp/mm |
| Resolution | 3.6lp | 3.6lp | 3.57lp |
[Table 1. Comparison of Proposed Device to Predicate Device]
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| Proposed Device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| Anatomical Sites | General | General | General |
| Exposure Mode | Manual, Auto(AED) | Manual, Auto(AED) | Manual, Auto(AED) |
| Wireless | Standard: | ||
| 802.11 a/b/g/n/ac | |||
| compliance | |||
| Frequency: 2.4 GHz/5GHz | |||
| Bandwidth: | |||
| 20MHz/40MHz/80MHz | |||
| MIMO: 2x2 | |||
| Rating | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz | 100-240V~, 50/60Hz |
There are no significant differences between the 14HK701G-W and the predicate devices 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, 14HK701G-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 predicate device 2 (K150165) 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.
The technological characteristics of the subject detector 14HK701G-W are similar to the predicate 17HK700G-W, and the only major difference is the smaller detector size.
8. Integration Specifications / Requirements for 14HK701G-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 |