The EXPD 4343P / EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Description

The EXPD 4343P / EXPD 3643P is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 4343P differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form. The EXPD 4343P / EXPD 3643P Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta. The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

AI/ML Overview

This document describes a 510(k) submission for the EXPD 4343P / EXPD 3643P Digital X-ray detector, which is intended to replace film or screen-based radiographic systems in general diagnostic procedures. The key aspect of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG, K192400).

The primary difference and focus of the study is the change in the TFT panel technology from amorphous silicon to IGZO. The manufacturer claims that IGZO offers improved performance characteristics such as lower resistance and leakage current, which can reduce signal delay and line noise.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are implicitly tied to demonstrating that the new device (EXPD 4343P/3643P) is equal to or better than the predicate device (EVS series) in terms of established X-ray device performance metrics: Detective Quantum Efficiency (DQE) and Modulation Transfer Function (MTF). Resolution is also a key parameter.

Parameter	Acceptance Criteria (Implicit - based on predicate or "equal or better")	Reported Device Performance (Subject Device)	Reported Performance (Predicate Device)
DQE (at 1.0 lp/mm)	Equal to or better than predicate DQE	EXPD 4343P: 50.0% EXPD 3643P: 52.3%	EVS 4343A: 52.9% EVS 4343AG: 27.2% EVS 3643A: 50.5% EVS 3643AG: 26.3%
MTF (at 2.0 lp/mm)	Equal to or better than predicate MTF	EXPD 4343P: 52.3% EXPD 3643P: 46.8%	EVS 4343A: 44.1% EVS 4343AG: 49.2% EVS 3643A: 44.5% EVS 3643AG: 46.3%
Resolution	3.5 lp/mm (Same as predicate)	3.5 lp/mm	3.5 lp/mm

Analysis of Performance vs. Criteria:

DQE: For the EXPD 4343P (50.0%), it is slightly lower than the EVS 4343A (52.9%) but significantly higher than the EVS 4343AG (27.2%). For the EXPD 3643P (52.3%), it is slightly higher than the EVS 3643A (50.5%) and significantly higher than the EVS 3643AG (26.3%). The statement "basically equal or worth than the predicate device" needs to be interpreted in the context of the range of predicate devices. The claim states that the subject device's performance is "equal or worth than the predicate device," which suggests that being comparable or slightly below the predicate in some aspects (like EXPD 4343P DQE vs EVS 4343A) is acceptable, especially when other aspects (like EXPD 3643P DQE vs EVS 3643AG or EXPD 4343P MTF vs EVS 4343A) are superior. The overall conclusion is that the new device meets the criteria of being "equal or worth than" the predicate, especially considering the performance improvements over the "AG" models of the predicate.
MTF: For the EXPD 4343P (52.3%), it is higher than both comparing EVS 4343A (44.1%) and EVS 4343AG (49.2%). For the EXPD 3643P (46.8%), it is higher than EVS 3643A (44.5%) and slightly higher than EVS 3643AG (46.3%). In all primary MTF comparisons, the subject device shows equal or better performance.
Resolution: Matches the predicate at 3.5 lp/mm.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that the data comes from a "bench test report" and "non-clinical performance testing."

Sample Size: The document does not specify a sample size for the testing of DQE, MTF, or resolution. These are typically measured on a single device following standardized procedures (e.g., IEC 62220-1). It implies testing on representative units of the EXPD 4343P and EXPD 3643P.
Data Provenance: The testing is "non-clinical," meaning it does not involve human subjects or retrospective/prospective medical data. It is laboratory performance testing. The manufacturer is DRTECH Corporation, based in the Republic of Korea.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission is for a digital X-ray detector, not an AI/CAD device. Therefore, there is no concept of "ground truth" established by human experts in the traditional sense for image interpretation. The ground truth for performance metrics like DQE, MTF, and resolution is established through standardized physical measurements and calculations as per recognized consensus standards (e.g., IEC 62220-1).

4. Adjudication Method for the Test Set

Not applicable, as this is objective engineering performance measurement, not subjective clinical interpretation of images requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or reported. This device is a hardware component (digital X-ray detector) and not an AI-powered diagnostic tool intended for human reader assistance. The study focuses purely on the physical performance characteristics of the detector itself.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

This is not an algorithm, but a hardware device. The reported performance metrics (DQE, MTF, Resolution) are the "standalone" or intrinsic performance of the detector itself, independent of interpretation by a human or an AI. So, in concept, the reported performance is standalone.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective physical measurements conducted according to international standards (specifically, IEC 62220-1 for DQE) and general engineering principles for X-ray detector characterization. It is not based on expert consensus, pathology, or outcomes data, as those would be relevant for diagnostic accuracy studies of interpreted images.

8. Sample Size for the Training Set

Not applicable. This is a hardware device. There is no "training set" in the machine learning sense for the device itself.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

Summary of the Study:

The study proving the device meets the acceptance criteria is a non-clinical bench test comparing the objective physical performance parameters (DQE, MTF, Resolution) of the new EXPD 4343P/3643P digital X-ray detectors against their predicate devices (EVS 4343A/AG / EVS 3643A/AG). The ground truth for these parameters is established through standardized measurement methodologies defined by international consensus standards, such as IEC 62220-1 for DQE. The study found that the new devices' performance was "equal or worth than" the predicate devices, thereby demonstrating substantial equivalence, particularly highlighting improvements in MTF over the predicate. No human readers, clinical data, or AI algorithms were involved in this specific performance assessment.

Summary

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November 22, 2019

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

DRTECH Corporation % Mr. Dongwook Shin Regulatory Affairs Responsible Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29 Dunchon-daero 541 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13216 REPUBLIC OF KOREA

Re: K193031

Trade/Device Name: EXPD 4343P/ EXPD 3643P Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 29, 2019 Received: October 30, 2019

Dear Mr. Dongwook Shin:

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

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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 medical devices and radiation-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,

For

Thalia T. Mills, Ph.D. Director 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) K193031

Device Name EXPD 4343P / EXPD 3643P

Indications for Use (Describe)

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

[As required by 21 CFR 807.92]

K193031

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

11/15/2019

2. Submitter's Information [21 CFR 807.92(a) (1)]

. Name of Sponsor: DRTECH Corporation Address: Suite No.1, 1 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, ● Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea ● Contact Name: DONGWOOK, SHIN
Telephone No.: + 82-31-779-7783 ●
Fax No .: + 82-31-779-7790 ●
. Email Address : dwshin@drtech.co.kr
Registration Number: 3005172103 ●
Name of Manufacturer: Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Trade Name: EXPD 4343P / EXPD 3643P ●
Common Name: Digital Flat Panel X-ray Detector ●
Classification Name: Stationary X-ray System ●
Classification Panel: Radiology ●
Classification Regulation: 21 CFR 892.1680 ●
Product Code: MOB ●
Device Class: . II

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number: K192400
Applicant: DRTECH Corporation
Trade Name: EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG ●
Classification Name: Stationary X-ray System ●
Classification Panel: Radiology
Classification Regulation: 21 CFR 892.1680 ●
Product Code: MQB ●
Device Class: . II

006 1/7 510(k) Summary

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5. Description of the Modified Device [21 CFR 807.92(a) (4)]

Addition of EXPD 4343P / EXPD 3643P: The differences between the subject devices and the predicate devices are TFT panel and performance (MTF & DQE). Predicate devices used Amorphous silicon TFT, however, subject devices use IGZO TFT.

IGZO is compound of indium(In)-gallium(Ga)-zinc(Zn)oxygen(O) and this compound is utilized as semiconductor material of TFT. Semiconductor material is only different material between conventional amorphous silicon TFT, that utilizing silicon as semiconductor material, and amorphous IGZO TFT. As IGZO has less resistance and leakage current on TFT switch off status than conventional amorphous silicon TFT, resistance capacity delay time for signal output could be reduced compare to conventional amorphous silicon TFT and also, line noise could be reduced compare to conventional amorphous silicon TFT. Difference between amorphous IGZO and conventional amorphous silicon TFT is shown in below table and right figure.

Image /page/4/Figure/6 description: The image shows a graph of transfer characteristics, with the x-axis representing gate voltage in volts and the y-axis representing log drain current in amperes. There are two curves on the graph, one for IGZO and one for a-Si. The graph shows that the IGZO curve has a lower leakage current and a lower Ron than the a-Si curve. The graph also indicates the regions where the TFT switch is off and on.

Category	IGZO TFT	a-Si TFT
Active Layer(SemiconductorMaterial)	indium(In)-gallium(Ga)-zinc(Zn)-oxygen(O)	Silicon(Si):H
Crystal structure	Amorphous	Amorphous
On Resistance(Ron)	0.1~0.9MΩ	1~10MΩ
Leakage current(TFT switch off status)	$10^{-15}$ A	$10^{-14}$ A

The x-ray generator, a necessary component for a complete diagnostic system, is not part of the device. The subject detector is supported by software, Econsole1 (cleared under K152172). The subject software is the same as the predicate.

6. Indication for Use [21 CFR 807.92(a)(5)]

006 2/7 510(k) Summary

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7. Technological Characteristics [21 CFR 807.92(a)(6)]

The EXPD 4343P / EXPD 3643P Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta.

The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

Comparisons with the predicate, devices show the technological characteristics of the EXPD 4343P / EXPD 3643P to be same to the predicate devices. EXPD 4343P / EXPD 3643P is functionally identical to the predicate devices.

Parameter	Subject Device	Predicate Device
510(K) Number	K193031	K192400
Manufacturer	DRTECH Corporation	DRTECH Corporation
Model Name	EXPD 4343PEXPD 3643P	EVS 4343A / EVS 4343AGEVS 3643A / EVS 3643AG
Classification Name	Stationary X-ray System
Classification Panel	Radiology
ClassificationRegulation	21 CFR 892.1680
Product Code	MQB
Device Class	Class II
Intended Use	The EXPD 4343P / EXPD 3643PDigital X-ray detector is indicated fordigital imaging solution designed forproviding general radiographicdiagnosis of human anatomy. Thisdevice is intended to replace film orscreen based radiographic systems inall general purpose diagnosticprocedures. This device is not intendedfor mammography applications	The EVS 4343A / EVS 4343AG / EVS3643A / EVS 3643AG Digital X-raydetector is indicated for digital imagingsolution designed for providing generalradiographic diagnosis of humananatomy. This device is intended toreplace film or screen basedradiographic systems in all generalpurpose diagnostic procedures. Thisdevice is not intended formammography applications.
Design	Panel Shape
	EXPD 4343P: Square Panel	EVS 4343A: Square PanelEVS 4343AG: Square Panel
	EXPD 3643P: Rectangular Panel	EVS 3643A: Rectangular PanelEVS 3643AG: Rectangular Panel
	DetectorSize
	EXPD 4343P: 17" X 17"	EVS 4343A: 17" X 17"EVS 4343AG: 17" X 17"
	EXPD 3643P: 13" X 17"	EVS 3643A: 13" X 17"EVS 3643AG: 13" X 17"
Parameter	Subject Device	Predicate Device
Dimensions	EXPD 4343P:460(W) x 483(L) x 15.5(H)EXPD 3643P:460(W) × 409(L) x 15.5(H)	EVS 4343A:460(W) x 483(L) x 15.5(H)EVS 4343AG:460(W) x 483(L) x 15.5(H)EVS 3643A:460(W) × 409(L) × 15.5(H)EVS 3643AG:460(W) × 409(L) × 15.5(H)
Pixel Pitch	140μm	140μm
Image Size	EXPD 4343P: 3,072 x 3,072EXPD 3643P: 2,560 x 3,072	EVS 4343A: 3,072 x 3,072EVS 4343AG: 3,072 x 3,072EVS 3643A: 2,560 x 3,072EVS 3643AG: 2,560 x 3,072
Scintillator & TFTMaterials	TFT -IGZOEXPD 4343P / EXPD 3643P: CsI	TFT -amorphous SiliconEVS 4343A/EVS 3643A: CsIEVS 4343AG/ EVS 3643AG: GOS
Performance	DQE	EXPD 4343P: 50.0 % at 1.0 lp/mmEXPD 3643P: 52.3 % at 1.0 lp/mm	EVS 4343A: 52.9% at 1.0 lp/mmEVS 4343AG: 27.2 % at 1.0 lp/mmEVS 3643A: 50.5% at 1.0 lp/mmEVS 3643AG: 26.3 % at 1.0 lp/mm
	MTF	EXPD 4343P: 52.3 % at 2.0 lp/mmEXPD 3643P: 46.8 % at 2.0 lp/mm	EVS 4343A: 44.1% at 2.0 lp/mmEVS 4343AG: 49.2% at 2.0 lp/mmEVS 3643A: 44.5% at 2.0 lp/mmEVS 3643AG: 46.3% at 2.0 lp/mm
	Resolution	3.5 lp/mm	3.5 lp/mm
Anatomical Sites	General Radiography	General Radiography
Power Supply	100~~240V~~, 50/60 Hz	100~~240V~~, 50/60 Hz
Component	PoE AdaptorLan cables(2 ea)AC Power CableEthernet Connector Bracket	PoE AdaptorLan cables(2 ea)AC Power CableEthernet Connector Bracket
CommunicationInterface	Wired: Ethernet	Wired: Ethernet
Parameter	Modified Device	Predicate Device	Remark
DQE	EXPD 4343P: 50.0% at 1.0 lp/mm	EVS 4343A: 52.9% at 1.0 lp/mm
	EXPD 3643P: 52.3 % at 1.0 lp/mm	EVS 4343AG: 27.2 % at 1.0 lp/mm
MTF	EXPD 4343P: 52.3 % at 2.0 lp/mm	EVS 4343A: 44.1 % at 2.0 lp/mm
	EXPD 3643P: 46.8 % at 2.0 lp/mm	EVS 4343AG: 49.2 % at 2.0 lp/mmEVS 3643A: 44.5 % at 2.0 lp/mmEVS 3643AG: 46.3 % at 2.0 lp/mm

8. Substantial Equivalence [21 CFR 807.92(b)]

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DRTECH

When compared to the predicate devices (K192400), the EXPD 4343P / EXPD 3643P presented in this submission have similar:

. Intended Use
Technological characteristics •
Operating principle •
Performance (Resolution) •
Communication Method
. Components

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Size
A few differences are as follows
. Performance (DQE and MTF)
. TFT Panel

There are no significant differences between the EXPD 4343P / EXPD 3643P and the predicate device(s) 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.

According to bench test report, it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device. As a result, subject devices performance is equal or worth than the predicate device.

9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]

The non-clinical performance testing constrains that the main physical values for comparison of Xray devices like DQE and MTF are basically equal or worth than the predicate device as following table:

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DRTECH

The EXPD 4343P / EXPD 3643P detector complies with the following international and FDArecognized consensus standards:

Recognition No.	Standard No.	Title of Standard
19-4	ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012	Medical electrical equipment -Part 1: General requirements forbasic safety and essentialperformance (IEC 60601-1:2005, MOD)
12-289	IEC 62220-1 Edition 1.02015-03	Medical electrical equipment-Characteristics of digital X-rayimaging devices Part 1-1:Determination of the detectivequantum efficiency Detectorsused in radiographic imaging
5-40	ISO 14971 Second edition2007-03-01	Medical devices - Applicationof risk management to medicaldevices
5-89	IEC 60601-1-6 Edition 3.1	Medical electrical equipment -Part 1-6: General requirementsfor basic safety and essentialperformance - Collateralstandard: Usability
12-300	PS 3.1 - 3.20 (2016)	Digital Imaging andCommunications in Medicine(DICOM) Set
19-8	IEC 60601-1-2 Edition 4.0	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests
13-32	ANSI AAMI IEC62304:2006	Medical device software -Software life cycle processes

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10. Conclusion [21 CFR 807.92(b)(3)]

The modified EXPD 4343P / EXPD 3643P detector is substantially equivalent to the currently marketed and predicate device (EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG - K192400) in terms of fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recogmized consensus standards, ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, ANSI AAMI IEC 62304:2006 and IEC 6220-1-1 which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.

The results of these tests demonstrate that The EXPD 4343P / EXPD 3643P meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, nonclinical performance data and safety testing demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.

Regulation Number and Section

§ 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.