(63 days)
The Flat Panel Digital X-ray Detector 14HQ721G-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.
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 highdefinition 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 qenerator. 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. This device does not have a dynamic exposure feature.
This document describes the LG Electronics Inc. Flat Panel Digital X-ray Detector 14HQ721G-B. The information provided outlines the device's acceptance criteria and the studies conducted to demonstrate its performance and substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device K221394) | Reported Device Performance (14HQ721G-B) |
|---|---|---|
| Scintillator | CsI | CsI |
| Imaging Area | 14 x 17 inches | 14 x 17 inches |
| Pixel Matrix | 2,500 x 3,052 pixels | 2,500 x 3,052 pixels |
| Pixel Pitch | 140 um | 140 um |
| High Contrast Limiting Resolution | 3.6 lp/mm | 3.6 lp/mm |
| Communication | Wired/Wireless | Wired/Wireless (Standard: 802.11 a/b/g/n/ac compliance, Frequency: 2.4 GHz/5GHz, Bandwidth: 20MHz/40MHz/80MHz, MIMO: 2x2) |
| DQE (Detective Quantum Efficiency) | Typ. 66% @ 0.1 lp/mm | Typ. 66% @ 0.1 lp/mm |
| MTF (Modulation Transfer Function) | Typ. 84% @ 0.5 lp/mm | Typ. 84% @ 0.5 lp/mm |
| Resolution | 3.6 lp | 3.6 lp |
| Anatomical Sites | General | General |
| Exposure Mode | Manual, Auto (AED) | Manual, Auto (AED) |
| Built-in AEC | X (Not present) | O (Present) |
| Semi Dynamic mode | O (Present) | O (Present) |
| Rating | 24V --- 2.1A | 24V --- 2.1A |
| Electrical Safety, EMC, & Performance | Compliance with relevant standards | Complies with ES60601-1:2005 (R)2012 & A1:2012 [Incl. AMD2:2021], IEC 60601-1-2 Edition 4.0 2014-02, FDA guidance "Radio Frequency Wireless Technology in Medical Devices", FDA guidance "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" |
| Software Validation | Verified and Validated | Software designed and developed according to internal process, verified and validated according to FDA guidance "The content of premarket submissions for software contained in medical devices" |
| Biocompatibility | Compliance with ISO 10993-1 | Complies with ISO 10993-1 and series |
| Imaging Performance Test | Conducted according to IEC 62220-1-1 | Conducted according to IEC 62220-1-1 |
| Cybersecurity | Compliance with FDA guidance | Complies with FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and "Postmarket Management of Cybersecurity in Medical Devices" |
| Labeling | Compliance with CFR Part 801 | Complies with CFR Part 801, and FDA guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications" |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "In this submission, clinical testing was not conducted, since nonclinical information is sufficient to show the substantial equivalence of the proposed devices to the predicate devices for the modifications." This implies that there was no specific "test set" of patient data for clinical performance evaluation. The substantial equivalence was primarily based on non-clinical engineering and performance testing comparing the proposed device to the predicate device.
Therefore, information on sample size, country of origin, and retrospective/prospective nature of a clinical test set is not applicable as no clinical test set was used for this submission's substantial equivalence demonstration.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set was used to establish ground truth for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC comparative effectiveness study was conducted as clinical testing was not performed. The submission relies on non-clinical data to demonstrate substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a Flat Panel Digital X-ray Detector, which is a hardware component for acquiring X-ray images. It includes firmware (software of moderate level of concern) that was validated. The performance tests (DQE, MTF, resolution) are measures of the standalone imaging capabilities of the device itself, without a human in the loop for interpretation beyond assessing image quality metrics. The comparison of these metrics to the predicate device effectively serves as a standalone performance assessment.
7. The Type of Ground Truth Used
The ground truth for performance was established through objective engineering and physical measurements based on established standards (e.g., IEC 62220-1-1 for DQE) and comparison to the predicate device's specifications. This is a technical ground truth for imaging performance rather than a clinical ground truth based on expert consensus, pathology, or outcomes data from patients.
8. The Sample Size for the Training Set
The document does not provide information on a training set size. This is consistent with the nature of the device being a digital X-ray detector, where performance is typically validated through engineering tests and comparison to a predicate, rather than through a machine learning model that requires a "training set" of data in the conventional sense. The "software update" mentioned includes the addition of the AEC mode, and this software was designed, developed, verified, and validated internally, but no specific training data for an AI algorithm is indicated.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is described. The ground truth for the device's technical performance was established through standardized physical measurements and component specifications, as detailed in point 7.
{0}------------------------------------------------
January 27, 2023
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 features the agency's acronym in a blue square, followed by the full name "U.S. Food & Drug Administration" in blue text.
LG Electronics Inc. % Daseul An RA associate 222, LG-RO PYEONGTAEK-SI, GYEONGGI-DO 17709 REPUBLIC OF KOREA
Re: K223546
Trade/Device Name: 14H0721G-B Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: November 25, 2022 Received: November 25, 2022
Dear Daseul An:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
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 (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 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,
2023.01.27
Lu Jiang 11:30:39
-05'00'
Lu Jiang, 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) K223546
Device Name 14HQ721G-B
Indications for Use (Describe)
The Flat Panel Digital X-ray Detector 14HQ721G-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) |
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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
Jan 25, 2023
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • Name of Sponsor: | LG Electronics Inc. |
|---|---|
| - Address: | 222, LG-ro, Pyeongtaek-si, Gyeonggi-do, 17709, |
| Republic of Korea | |
| • Name of Manufacturer: | LG Electronics Inc. |
| - Address: | 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do, 39368, |
| Republic of Korea | |
| • Contact Name: | Daseul An / Regulatory Affairs Associate |
| - Telephone No.: | +82-10-8914-0116 |
| - Email Address: | daseul.an@lge.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device/Model Name | 14HQ721G-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}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follows;
Predicate Device
- 510(k) Number: ● K221394
- Applicant: ● LG Electronics Inc.
- Trade/Device Name: 14HQ701G-B
- Common Name: Flat Panel Digital X-ray Detector
- Classification Name: Stationary X-ray System
- Regulation Number: 21 CFR 892.1680
- Classification Product MQB Code ● Device Class: ll
- 510(k) Review Panel: Radiology
The predicate devices have not been subject to a design-related recall.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
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 highdefinition 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 qenerator. 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. This device does not have a dynamic exposure feature.
14HQ721G-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.
Below is a summary of the information from the 14HQ721G-B user manuals covering key electromechanical and computer requirements needed for X-ray system interface and integration.
-
- Mechanical interface requirements.
- Computer requirements 2.
-
- Data communication interface requirements
-
- Electrical power requirements
- ഗ് X-ray trigger interface requirements
Neither the 14HQ721G-B nor its software acts as an X-ray generator controller, and therefore, the device is not subject to Electronic Product Radiation Control (EPRC) performance standards and reporting requirements.
The built-in AEC (Automatic Exposure Control) in 14HQ721G-B is sensors which convert the amount of the X-ray emitted from the X-ray generator into the electric signals and deliver them to the X-ray generator connected with the X-ray detector via the control box. The X-ray generator determines for
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and the colors are eye-catching.
itself whether to stop x-ray emission based on these electrical signals. The 14HQ721G-B does not directly control the X-ray generator.
6. Indications for use [21 CFR 807.92(a)(5)]
The Flat Panel Digital X-ray Detector 14HQ721G-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 14HQ721G-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.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and the colors are eye-catching.
8. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
There are no significant differences in the technological characteristics of the proposed device compared to the predicate device which would adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the 14HQ721G-B and the predicate device:
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| K Number | K223546 | K221394 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | Same |
| Trade Name | 14HQ721G-B | 14HQ701G-B | - |
| Common Name | Flat Panel Digital X-ray Detector | Flat Panel Digital X-ray Detector | Same |
| Product Code | MQB | MQB | Same |
| RegulationNumber | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| 510(k) ReviewPanel | Radiology | Radiology | Same |
| Indications forUse | The Flat Panel Digital X-ray Detector14HQ721G-B is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Notto be used for mammography. | The Flat Panel Digital X-ray Detector14HQ701G-B is indicated for digitalimaging solution designed forgeneral radiographic system forhuman anatomy. It is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Notto be used for mammography. | Same |
| Intended use | The Flat Panel Digital X-ray Detector14HQ721G-B is a prescriptiondevice, and it is not intended to beused for mammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. | The Flat Panel Digital X-ray Detector14HQ701G-B is a prescriptiondevice, and it is not intended to beused for mammography.- The detector is indicated fordigital imaging solutiondesigned for generalradiographic system forhuman anatomy- The detector is indicated toreplace film or screen basedradiographic systems in allgeneral purpose diagnosticprocedures. | Same |
| Detector | |||
| Scintillator | Csl | Csl | Same |
| Imaging Area | 14 x 17 inches | 14 x 17 inches | Same |
| Pixel Matrix | 2.500 x 3.052 pixels | 2.500 x 3.052 pixels | Same |
| [Table 1, Comparison of Proposed Device to Predicate Device] | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------------------- | -- |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for LG Electronics. The logo consists of a stylized red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
| Proposed Device | Predicate Device | Note | |
|---|---|---|---|
| Pixel Pitch | 140 um | 140 um | Same |
| High ContrastLimitingResolution(LP/mm) | 3.6 lp/mm | 3.6 lp/mm | Same |
| Communication | Wired/Wireless | Wired/Wireless | Same |
| DQE | Typ.66% @0.1lp/mm | Typ.66% @0.1lp/mm | Equivalent |
| MTF | Typ.84% @0.5lp/mm | Typ.84% @0.5lp/mm | Equivalent |
| Resolution | 3.6lp | 3.6lp | Same |
| AnatomicalSites | General | General | Same |
| Exposure Mode | Manual, Auto (AED) | Manual, Auto (AED) | Same |
| Built-in AEC | O | X | Different |
| Semi Dynamicmode | O | O | Same |
| Wireless | Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 2x2 | Standard:802.11 a/b/g/n/ac complianceFrequency: 2.4 GHz/5GHzBandwidth: 20MHz/40MHz/80MHzMIMO: 2x2 | Same |
| Rating | 24V --- 2.1A | 24V --- 2.1A | Same |
| Gap Analysis | The difference from the predicate device (14HQ701G-B) is the addition of the built-inAEC mode and the software update, which would not adversely affect the safety andthe effectiveness of the product. The software update includes the addition of the AECmode.The proposed device (14HQ721G-B) has shown similar performance (DQE, MTF) as thepredicate device. Therefore, the proposed device is substantially equivalent to thepredicate device. |
** Semi Dynamic mode is a function that can transmit five images per second to the PC.
There are no significant differences between the 14HQ721G-B and the predicate device that would adversely affect the use of the product. It is concluded that the 14HQ721G-B is substantially equivalent to the predicate devices in design, function, materials, operational principles and intended use. The electrical safety test, EMC test and the performance test were conducted on the proposed devices, and the software was validated.
In this submission, clinical testing was not conducted, since nonclinical information is sufficient to show the substantial equivalence of the proposed devices to the predicate devices for the modifications.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
9. Non-Clinical Test summary
The 14HQ721G-B complies with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
1 ) Electrical Safety, Electromagnetic Compatibility and Performance:
The 14HQ721G-B complies with the electrical safety and electromagnetic compatibility requirements established by the standards.
| StandardsNo. | StandardsOrganization | Standard Title | Version | PublicationYear |
|---|---|---|---|---|
| ES60601-1 | AAMI | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD)[Including Amendment 2 (2021)] | ES60601-1:2005(R)2012& A1:2012[Incl.AMD2:2021] | 2021 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2:General Requirements for Safety - CollateralStandard: Electromagnetic Compatibility -Requirements and Tests | 60601-1-2Edition 4.02014-02 | 2014 |
| - | FDA | Radio Frequency Wireless Technology inMedical Devices | August 14 | 2013 |
| - | FDA | Guidance for the Submission of 510(k)s forSolid State X-ray Imaging Devices | September 1 | 2016 |
2) Software Validation
The 14HQ721G-B includes the software of MODERATE level of concern as a firmware. The difference from the predicate device is the addition of the AEC mode. The software was designed and developed according to the internal 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 was conducted according to:
510(k) Summary
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
- IEC 62220-1-1, 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
6) Label
- CFR Part 801
- Pediatric Information for X-ray Imaging Device Premarket Notifications, on November 28, 2017
10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between 14HQ721G-B and the predicate device, K221394 that would adversely affect the use of the product. The proposed device is substantially equivalent to the predicate device in indications for use and technology characteristics.
11. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food & Druq and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification of LG Electronics, it is concluded that the 14HQ721G-B is substantially equivalent in safety and effectiveness to the predicate device as described herein.
§ 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.