EXTRON 3;EXTRON 6
Device Facts
| Record ID | K261413 |
|---|---|
| Device Name | EXTRON 3;EXTRON 6 |
| Applicant | DRTECH Corporation |
| Product Code | OWB · Radiology |
| Decision Date | Aug 19, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine (※ This device is not intended for mammography applications.)
Device Story
Mobile fluoroscopic X-ray system; C-arm main body and monitor cart. Inputs: X-ray beams directed at patient anatomy. Principle: X-ray photons converted to light, then to electrical signals via flat panel detector; signals digitized, processed, and displayed. Used in OR/clinical settings by physicians/surgeons/technicians for real-time imaging during surgery/treatment. Output: High-resolution X-ray images displayed on monitor; saved/transmitted to hospital PACS for diagnostic support. Benefits: Real-time visualization for surgical guidance; improved workflow via digital storage/transmission.
Clinical Evidence
No clinical trials; bench testing only. Clinical image quality evaluated by qualified experts comparing subject device images to predicate device images. Results confirmed equivalent image quality for indicated anatomies and populations.
Technological Characteristics
Mobile C-arm system; X-ray tube (stationary/rotating anode); flat panel detector; digital imaging system; collimator; generator; monitor cart. Connectivity: PACS integration. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-2-43, IEC 62304, ANSI UL 2900-1, IEC 81001-5-1.
Indications for Use
Indicated for patients of all ages (neonates to adults) requiring X-ray radiography or fluoroscopy during surgery or treatment, including emergency injury, orthopedic, neurosurgery, bone surgery, anesthesiology, urology, gynecology, and internal medicine procedures. Not intended for mammography.
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device 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
- EXTRON 3, EXTRON 5, EXTRON 7 (K250010)
Reference Devices
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
August 19, 2026
Youngeun Lee
% DRTECH Corporation
Assistant Manager
Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
SEONGNAM-SI, GYEONGGI 13216 3216
REPUBLIC OF KOREA
Re: K261413
Trade/Device Name: Extron 3; Extron 6
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, OXO, JAA
Dated: April 10, 2026
Received: July 24, 2026
Dear Youngeun Lee:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261413 - Youngeun Lee
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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-
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K261413 - Youngeun Lee
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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,
for
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
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261413 |
| Please provide the device trade name(s). | | ? |
| EXTRON 3; EXTRON 6 | | |
| Please provide your Indications for Use below. | | ? |
| EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine (※ This device is not intended for mammography applications.) | | |
| Please select the types of uses (select one or both, as applicable). | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? |
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K261413
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)]
August 19, 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: Youngeun Lee
Telephone No.: +82-31-779-7705
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)]
Trade Name: EXTRON 3, EXTRON 6
Common Name: Mobile Fluoroscopic X-ray System
Classification Name: Image-intensified fluoroscopic x-ray system
Classification Panel: Radiology
Classification Regulation: 21 CFR 892.1650
Product Code: OWB, OXO, JAA
Device Class: II
510(k) Summary
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DRTECH
# 4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| | Predicate Device | Reference 1 | Reference 2 |
| --- | --- | --- | --- |
| 510(k) Number: | K250010 | K122234 | K142708 |
| Applicant: | DRTECH Corporation | GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC | PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
| Trade Name: | EXTRON 3, EXTRON 5, EXTRON 7 | OEC 9900 ELITE | VERADIUS UNITY |
| Classification Name: | Image-intensified fluoroscopic x-ray system | | |
| Classification Panel: | Radiology | | |
| Classification Regulation: | 21 CFR 892.1650 | | |
| Product Code: | OWB, JAA, OXO | | |
| Device Class: | II | | |
# 5. Description of the Device [21 CFR 807.92(a) (4)]
EXTRON Series are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
The EXTRON Series are composed of a C-arm main body and a monitor cart. The C-arm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program.
The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.
X-rays can penetrate into the human body through a two-step conversion process.
X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.
# 6. Indications for Use [21 CFR 807.92(a)(5)]
EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine
(※ This device is not intended for mammography applications.)
510(k) Summary
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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 EXTRON Series are designed as a combination of components, including a C-arm, X-ray tube and housing, flat panel detector, digital imaging system, collimator, generator, and monitor cart. Its purpose is to provide X-ray images of a patient's anatomy during surgery or treatment.
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 (EXTRON 3/6) with Predicate and Reference Devices
| Parameter | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- |
| 510(K) Number | K261413 | K250010 | K122234 | K142708 | - |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC | Philips Medical Systems Nederland B.V. | - |
| Model Name | EXTRON 3, EXTRON 6 | EXTRON 3, EXTRON 5, EXTRON 7 | OEC 9900 ELITE | Veradius Unity | - |
| Classification Name | Image-intensified fluoroscopic x-ray system | Image-intensified fluoroscopic x-ray system | Image-intensified fluoroscopic x-ray system | Image-intensified fluoroscopic x-ray system | Equivalent |
| Classification Panel | Radiology | | | | Radiology |
| Classification Regulation | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | 21 CFR 892.1650 | Equivalent |
| Product Code | OWB, OXO, JAA | OWB, OXO, JAA | OWB, JAA, OXO | OWB, OXO, JAA | Equivalent |
| Device Class | Class II | Class II | Class II | Class II | Equivalent |
| Indications for Use | EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or | EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or | The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of | The proposed Veradius Unity device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, radiologists, and | Equivalent |
510(k) Summary
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# DRTECH
| Parameter | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- |
| | treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine (※ This device is not intended for mammography applications.) | treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis. Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine (※ This device is not intended for mammography applications.) | clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. | radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device. The device is to be used in healthcare facilities both inside and outside the operating room, in sterile as well as non-sterile environments, in a variety of procedures. Applications • Orthopedic • Neuro • Abdominal • Vascular • Thoracic • Cardiac | |
| Target population | Patients who need X-ray radiography or fluoroscopy images Adults and Pediatrics | Patients who need X-ray radiography or fluoroscopy images Adults and Pediatrics | Patients who need fluoroscopic and spot-film images | Patients who need diagnostic, interventional and surgical procedures, except neonates (birth to one month) | Equivalent |
| Mobile Platform | Yes | Yes | Yes | Yes | Equivalent |
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# DRTECH
| Parameter | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- |
| X-ray tube | EXTRON 3 : Stationary Anode EXTRON 6: Rotating Anode | EXTRON 3 : Stationary Anode EXTRON 5 : Rotating Anode EXTRON 7: Rotating Anode | Rotating Anode | Rotating Anode | Equivalent |
| X-ray Generator Manufacturer / Model | EXTRON 3 : Powersite / MB-C5B EXTRON 6 : IMD / HF1 R/8 | EXTRON 3 : Powersite / MB-C5B EXTRON 5, EXTRON 7 : IMD / HF1 R/8 | - | - | Equivalent |
| X-ray Tube Manufacturer / Model | EXTRON 3 : RADII / KL188-0.6/1.2-125 EXTRON 6 : IAE / RTM 780 H | EXTRON 3 : EXTRON 3 : RADII / KL188-0.6/1.2-125 EXTRON 5, EXTRON 7 : IAE / RTM 780 H | - | - | Equivalent |
| Radiographic Mode | [Optional] kV Range : 40 to 120kV mA Range EXTRON 3 - Up to 100mA EXTRON 6 - Up to 100mA | kV Range : 40 to 120kV mA Range EXTRON 7 - Up to 150mA EXTRON 5 - N/A EXTRON 3 - Up to 100mA | kV Range : 40 to 120kV mA Range : Up to 150mA | kV Range : 40 to 120kV mA Range : Up to 125mA | Equivalent |
| Fluoroscopic Mode | kV Range : 40 to 120kV mA Range : EXTRON 3 - Up to 30mA EXTRON 6 - Up to 60mA | kV Range : 40 to 120kV mA Range : EXTRON 3 - Up to 30mA EXTRON 5 - Up to 40mA EXTRON 7 - Up to 60mA | kV Range : 40 to 120kV mA Range : - Normal : 0.2- 10 mA - High Level Fluoro : 1.0 - 40 mA | kV Range : 40 to 120kV mA Range : 1 to 60mA | Equivalent |
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# DRTECH
| Dimension | | Immersion Depth EXTRON 3 - 73cm EXTRON 6 - 74cm Free Space : 80cm Orbital movement EXTRON 3 - 165°, 180° EXTRON 6 - 165°, 180° | Immersion Depth EXTRON 3 - 73cm EXTRON 5 - 74cm EXTRON 7 - 74cm Free Space : 80cm Orbital movement : 165° | Immersion Depth : 84cm Free Space : 79cm Orbital movement : 145° | Immersion Depth : 73cm Free Space : 77cm Orbital movement : 145° | Equivalent : Alteration in the dimension does not give rise to any novel concerns regarding safety and effectiveness. Additionally, due to the greater scope of movement, the Subject device offers a higher degree of convenience compared to the Predicate device. |
| --- | --- | --- | --- | --- | --- | --- |
| Laser Guide | | Yes | Yes | Yes | Yes | Equivalent |
| Foot Switch | | Wired Foot Switch Wireless Foot Switch | Wired Foot Switch Wireless Foot Switch | Wired Foot Switch Wireless Foot Switch | Wired Foot Switch Wireless Foot Switch | Equivalent |
| Detector | Pixels | EXPD 2121PB : 1500 x 1500 pixels EXPD 2323PB:1536 x 1536 pixels | EXPD 2121P : 1500 x 1500 pixels EXPD 2323P : 1536 x 1536 pixels | 21 cm FPD : 1536 x 1496 pixels 31 cm FPD : 1548 x 1524 pixels | 1560 x 1420 pixels | Equivalent |
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# DRTECH
| Parameter | | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- | --- |
| | | EXPD 3030P : 2048 x 2048 pixels | EXPD 2323PB:1536 x 1536 pixels EXPD 3030P : 2048 x 2048 pixels | | | |
| | DQE | 55% @1lp/mm | 55% @1lp/mm | 21 cm FPD : Typical 63% @0.5lp/mm 31 cm FPD : Typical 62% @0.5lp/mm | 70% @ 0p/mm | Equivalent |
| | MTF | 55% @1lp/mm | 55% @1lp/mm | - | 59% @ 1lp/mm | Equivalent |
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DRTECH
# **8. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]**
The EXTRON Series 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 - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below. |
| ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] |
| 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 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
| IEC 60601-2-43 Edition 3.0 2022-12 | Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
| IEC 60601-2-43 Edition 2.2 2019-10 CONSOLIDATED VERSION | Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures |
| IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes |
| ANSI UL 2900-1 First Edition 2017 | Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
510(k) Summary
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DRTECH
| 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 |
| --- | --- |
And EXTRON Series 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 |
| Guidance for Industry and FDA Staff: Content of Premarket Submissions for Device Software Functions | June 14, 2023 |
| Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray Imaging Devices Conformance with IEC Standards | May 8, 2019 |
| Guidance for Industry and FDA Staff: Electromagnetic Compatibility (EMC) of Medical Devices | June 3, 2022 |
| Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Medical Devices | February 3, 2016 |
| Guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | September 27, 2023 |
Bench testing and related documentation performed in accordance with Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
Sample clinical images representative of the indicated anatomies and populations have been taken for both the proposed devices (EXTRON 3, EXTRON 6) and the predicate devices (EXTRON 5/7/3(K250010)). These images have been reviewed and compared by qualified clinical experts. As a result of this evaluation, it has been confirmed that the EXTRON Series devices provide equivalent image quality to the predicate devices.
## 9. Summary of Clinical Data [21 CFR 807.92(b)(2)]
Clinical images were taken and reviewed by qualified clinicians to support SE (see Section 8 for more details).
## 10. Conclusion [21 CFR 807.92(b)(3)]
The EXTRON Series are substantially equivalent to the currently marketed predicate devices (EXTRON 5/7/3(K250010)) in terms of design, fundamental scientific technology, and indications for use, safety, and effectiveness.
Substantial equivalence for Mobile fluoroscopic X-ray System was demonstrated through the non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-2-43, IEC 62304, ANSI UL 2900-1, and IEC 81001-5-1.
The comparison of technological characteristics, non-clinical performance data and safety testing demonstrate that the EXTRON Series are substantially equivalent to the predicate devices.
510(k) Summary
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