EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
Device Facts
| Record ID | K260227 |
|---|---|
| Device Name | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H |
| Applicant | DRTECH Corporation |
| Product Code | KPR · Radiology |
| Decision Date | Sep 8, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
Indications for Use
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
Device Story
Stationary X-ray system; generates radiographic images of human anatomy. Components: X-ray generator, tube, collimator, tube support unit, bucky stand, patient table, flat panel detector, console. Operation: User sets parameters (kV, mA, exposure time); generator irradiates patient; detector captures X-rays; workstation processes data into images. Used in clinical settings by healthcare professionals. Output: Radiographic images for diagnostic review. Benefits: Enables visualization of anatomical structures for clinical decision-making.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Stationary X-ray system; high-frequency generator (40-50kW); flat panel detector; manual/auto collimation; floor/ceiling/synchro/universal support units; fixed/4-way/6-way tables. Connectivity: Workstation-based image management. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54, IEC 62304, IEC 81001-5-1, UL ANSI 2900-1.
Indications for Use
Indicated for generating radiographic images of human anatomy for general diagnostic purposes. Not intended for mammography applications.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- EXSYS DEXi (K242847)
Submission Summary (Full Text)
{0}
[LOGO]
FDA U.S. FOOD & DRUG ADMINISTRATION
September 8, 2026
DRTECH Corporation
% Hanbyul Kim
Manager
Suite #1, 2 Floor /Suite # 2, 3 Floor
29 Dunchon-Daero 541 Beon-Gil
Jungwon-Gu, Seongnam-Si
Gyeonggi-do 13216
KOREA
Re: K260227
Trade/Device Name: EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H)
Regulation Number: 21 CFR 892.1680
Regulation Name: Stationary X-Ray System
Regulatory Class: Class II
Product Code: KPR
Dated: August 11, 2026
Received: August 12, 2026
Dear Hanbyul Kim:
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 (the 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 available 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.
{1}
K260227 - Hanbyul Kim
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
{2}
K260227 - Hanbyul Kim
Page 3
assistance/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,
Lu Jiang, Ph.D.
Assistant Director
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K260227
Device Name
EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P);
EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H);
Indications for Use (Describe)
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
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."*
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{4}
510kNumber:K260227
DRTECH
# 510(k) Summary
[As required by 21 CFR 807.92]
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)]
01/20/2026
# 2. Submitter's Information [21 CFR 807.92(a) (1)]
Name of Sponsor: DRTECH Corporation
Address: Suite No.1, 2 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13216, Republic of Korea
Contact Name: Hanbyul Kim
Telephone No.: +82-31-779-7720
Fax No.: +82-31-779-7790
Email Address: drtechra@drtech.com
Registration Number: 3005172103
Name of Manufacturer: Same as Sponsor
# 3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
Device Name : EXSYS DEXi (EXSYS DEXi-S40S);
EXSYS DEXi (EXSYS DEXi-S40P);
EXSYS DEXi (EXSYS DEXi-S40T);
EXSYS DEXi (EXSYS DEXi-S50H);
Common Name: Diagnosis X-Ray System
- Classification Name: Stationary x-ray system
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1680
Product Code: KPR
Device Class: II
1/8
510(k) Summary
EXSYS DEXi
{5}
DRTECH
# 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
510(k) Number: K242847
- Applicant: DRTECH Corporation
Trade(Brand) Name: EXSYS DEXi
Device(Model) Name : EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); EXSYS DEXi (EXSYS DEXi-D503T-FRA);
- Classification Name: Stationary x-ray system
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1680
Product Code: KPR
Device Class: II
# 5. Description of the Device [21 CFR 807.92(a) (4)]
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
The EXSYS DEXi composed of a x-ray generator, tube, collimator, tube support unit, bucky stand, patient table, flat panel detector and console.
The operation principle of the device involves utilizing the X-ray generator, based on examination parameters set by the user such as tube voltage, tube current, exposure time to irradiate the specific area of the patient being examined with X-rays. The X-rays that have been emitted are then processed into images through a detector after passing through the patient.
# 6. Indication for Use [21 CFR 807.92(a)(5)]
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
2/8
510(k) Summary
EXSYS DEXi
{6}
DRTECH
# 7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device [21 CFR 807.92(a)(6), 21 CFR 807.92(b)]
The EXSYS DEXi composed of a x-ray generator, tube, collimator, tube stand, bucky stand, patient table, flat panel detector and console.
It is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
The subject device has the same fundamental scientific technologies as the predicate devices. The technological comparison table below demonstrates the comparability of the technological characteristics of the new device and the currently cleared predicate devices. The Technological differences do not affect the intended use of the device.
The table 1 below compares the main performance data of the subject device with the predicate devices to substantiate equivalence of the subject device and predicates.
Table 1. Comparison of the Subject Device to the Predicate Device Substantial Equivalence
| Parameter | Subject Device | Predicate Device | Discussion |
| --- | --- | --- | --- |
| 510(K) Number | - | K242847 | N/A |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | N/A |
| Device/Brand Name | EXSYS DEXi | EXSYS DEXi | N/A |
| Model Name | EXSYS DEXi-S40S EXSYS DEXi-S40P EXSYS DEXi-S40T EXSYS DEXi-S50H | EXSYS DEXi-A401S-FRM EXSYS DEXi-A402S-FRM EXSYS DEXi-A401P-FRM EXSYS DEXi-A402P-FRM EXSYS DEXi-A503T-FRM EXSYS DEXi-D401S-FRM EXSYS DEXi-D402S-FRM EXSYS DEXi-D401P-FRM EXSYS DEXi-D402P-FRM EXSYS DEXi-D503T-FRM EXSYS DEXi-D401S-FRA EXSYS DEXi-D402S-FRA EXSYS DEXi-D401P-FRA EXSYS DEXi-D402P-FRA EXSYS DEXi-D503T-FRA | N/A |
| Classification Name | Stationary x-ray system | Stationary x-ray system | Identical |
| Classification Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 | Identical |
| Product Code | KPR | KPR | Identical |
| Device Class | Class II | Class II | Identical |
| Intended Use | The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of | The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of | Identical |
3/8
510(k) Summary
EXSYS DEXi
{7}
DRTECH
| | examination using radiation exposure with DR. This system is not intended for mammography applications. | examination using radiation exposure with DR. This system is not intended for mammography applications. | |
| --- | --- | --- | --- |
| **High Frequency X-ray Generator** | | | |
| Output Power | 40kW, 50kW | 40kW, 50kW | Identical |
| Generator models | DRTECH Generator : DXG-40S DXG-40P DXG-40T DXG-50H | DRTECH Generator : DXG-40S DXG-40P DXG-50T | Additional types of generators have been added. We have conducted tests regarding the addition of these collimators, and there is "no negative impact on safety or efficacy." Furthermore, there are no new potential risks or increased safety hazards related to these differences. |
| Phase | Single-Phase : DXG-40S, DXG-40P Three-Phase : DXG-40T, DXG-50H | Single-Phase : DXG-40S, DXG-40P Three-Phase : DXG-50T | Identical |
| Line voltage | DXG-40S, DXG-40P : 220~230VAC DXG-40T, DXG-50H : 230/380/400/480VAC | DXG-40S, DXG-40P : 220~230VAC DXG-50T : 230/380/400/480VAC | Identical |
| kV Range | DXG-40S, DXG-40P, DXG-40T : 40~125kV, 1kV step DXG-50H : 40~150kV, 1kV step | DXG-40S, DXG-40P : 40~125kV, 1kV step DXG-50T : 40~150kV, 1kV step | Identical |
| mA Range | DXG-40S, DXG-40P, DXG-40T : 10 to 500mA DXG-50H : 10 to 630mA | DXG-40S, DXG-40P : 10 to 500mA DXG-50T : 10 to 630mA | Identical |
| **Image Acquisition** | | | |
| Detector | Used with DRTECH Detector K193017 : EVS 4343W, EVS 4343WP, EVS 3643W, EVS 3643WP K192400 : EVS 4343A, EVS 3643A K193031 : EXPD 4343P, EXPD 3643P K243443 : EXPD 4343N1, EXPD 4343N, EXPD 3643N1, EXPD 3643N, EXPD | Used with DRTECH Detector K193017 : EVS 4343W, EVS 4343WP, EVS 3643W, EVS 3643WP K192400 : EVS 4343A, EVS 3643A K193031 : EXPD 4343P, EXPD 3643P K223124 : EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG K231959 : | The system has been tested and there is "No negative impact on safety or efficacy" and there are no new potential or increased safety risks concerning this difference. All the flat panel detectors have been previously cleared by 510(k). |
4/8
510(k) Summary
EXSYS DEXi
{8}
DRTECH
| | 4343U1, EXPD 4343NU, EXPD 3643U1, EXPD 4343NU, EXPD 4343NP, EXPD 3643NP | EXPD 4357, EXPD 4357P K232082 : EXPD 4343S K232753 : EXPD 3643D, EXPD 4343D | |
| --- | --- | --- | --- |
| **Image Management Software** | | | |
| Software | EConsole1 (K231225) EConsole2 (K240243) | EConsole1 (K231225) EConsole2 (K240243) | Identical |
| Image viewing | Available | Available | Identical |
| Image search | Available | Available | Identical |
| Image storage | Available | Available | Identical |
| Image annotation | Available | Available | Identical |
| Image measurement | Available | Available | Identical |
| Image processing | Available | Available | Identical |
| Image stitch | Available | Available | Identical |
| Generator Control | Available | Available | Identical |
| **X-ray Tube** | | | |
| Tube models | E7239X, E7252X | E7239X, E7242X, E7884X | - |
| Max. Tube Voltage | E7239X : 125 kV E7252X : 150 kV | E7239X, E7242X : 125 kV E7884X : 150 kV | Identical |
| Anode Heat Capacity | E7239X : 140 kHU E7252X : 300 kHU | E7239X : 140 kHU E7242X : 200 kHU E7884X : 300 kHU | Although there are some differences in tube specification, the system has been tested and there is “No negative impact on safety or efficacy” and there are no new potential or increased safety risks concerning this difference. |
| **Collimator** | | | |
| Collimator Models | CRUX FR04 | M-38 R 221/A DHHS R 225 ACS DHHS | - |
| Adjustment method | Manual | Manual, Auto | Although there are some differences in collimator adjustment method, the system has been tested and there is “No negative impact on safety or efficacy” and there are no new potential or increased safety risks concerning this difference. |
| **Tube support unit** | | | |
| Models | LSS-2000, SC-4200, SD-3100, SU-2000 | DTS-M DTS-A | - |
5/8
510(k) Summary
EXSYS DEXi
{9}
DRTECH
| Operation Method | LSS-2000 : Manual SC-4200 : Auto SD-3100 : Auto SU-2000 : Auto | Manual, Auto | Different types of tube support unit has been added. We have conducted tests regarding this addition, and there is "no negative impact on safety or efficacy." Furthermore, there are no new potential risks or increased safety hazards related to these differences. |
| --- | --- | --- | --- |
| Type | LSS-2000 : Floor-supported type SC-4200 : Ceiling type SD-3100 : Synchro Type SU-2000 : Universal Stand | Floor-supported type | |
| **Bucky Stand** | | | |
| Models | LSS-1000 | DBS-43M LLD 129 With Rotation LLD 129 Compact DBS-57M DBS-43A DBS-57A | Although there are some differences in bucky stand types, the system has been tested and there is "No negative impact on safety or efficacy" and there are no new potential or increased safety risks concerning this difference. |
| Operation Method | Manual | Manual, Auto | |
| Type | Floor-supported type | Floor-supported type | Identical |
| **Patient Table** | | | |
| Models | ST-1000 ST-2100 ST-3300 | DPT-4A DPT-6A DPT-4B DPT-6B DPT-6AT DPT-6BT | Although there are some differences in patient table types, the system has been tested and there is "No negative impact on safety or efficacy" and there are no new potential or increased safety risks concerning this difference. |
| Type | Fixed (Basic) : ST-1000 4 way : ST-2100 6 way : ST-3300 | 4 way : DPT-4A, DPT-4B 6 way : DPT-6A, DPT-6B, DPT-6AT, DPT-6BT | |
| Fixed method | Electromagnet | Electromagnet | Identical |
There are no significant differences between the subject Device and the predicate device that would have a negative impact on the product's use. Therefore, the subject device is considered substantially equivalent to the predicate device.
6/8
510(k) Summary
EXSYS DEXi
{10}
DRTECH
# **9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]**
The EXSYS DEXi comply with the following international and FDA-recognized consensus standards list in Table 2.
Table 2. International and FDA-recognized consensus standards
| Standards development organization, reference number, and date | Standard name |
| --- | --- |
| ISO 14971: Third Edition 2019-12 | Medical devices - Application of risk management to medical devices |
| IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION | Medical devices - Part 1: Application of usability engineering to medical devices |
| IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| IEC 60601-2-28 Edition 3.0 2017-06 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-54 Edition 2.0 2022-09 CONSOLIDATED VERSION | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes |
| UL ANSI 2900-1 First Edition 2017 | Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
| IEC 81001-5-1 Edition 1.0 2021-12 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle |
7/8
510(k) Summary
EXSYS DEXi
{11}
DRTECH
And EXSYS DEXi comply with the FDA guidance documents listed in Table 3.
Table 3. FDA Guidance Documents
| Title of Guidance Document | Issue Date |
| --- | --- |
| Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | July 28, 2014 |
| Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff | Nov 28, 2017 |
| Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray Imaging Devices Conformance with IEC Standards | Feb 21, 2023 |
| Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff | June 14, 2023 |
| Cybersecurity in Medical Devices Quality System Considerations and Content of Premarket Submissions | June 27, 2025 |
The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.
#### 10. Summary of Clinical Data [21 CFR 807.92(b)(2)]
Not Applicable
Clinical studies are unnecessary to validate the safety and effectiveness of the Stationary x-ray system, EXSYS DEXi, the subject of this 510(k) notification.
#### 11. Conclusion [21 CFR 807.92(b)(3)]
The EXSYS DEXi is substantially equivalent to the currently marketed predicate device (K242847) in terms of technical characteristics, general function, application and indications for use, safety, and effectiveness.
Substantial equivalence for Stationary X-ray System(EXSYS DEXi) was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, IEC 81001-5-1 and ANSI UL 2900-1.
The comparison of technological characteristics, non-clinical performance data and safety testing demonstrate that the EXSYS DEXi is substantially equivalent to the predicate devices.
8/8
510(k) Summary
EXSYS DEXi
