EXTRON 3; EXTRON 5; EXTRON 7
Device Facts
| Record ID | K250010 |
|---|---|
| Device Name | EXTRON 3; EXTRON 5; EXTRON 7 |
| Applicant | DRTECH Corporation |
| Product Code | OWB · Radiology |
| Decision Date | Jun 10, 2025 |
| 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 photons generated by tube, collimated, and captured by flat panel detector. Process: Two-step conversion (photons to light, light to electrical signals); signals digitized, processed, and displayed on monitor. Operated by healthcare professionals in clinical settings (OR, emergency). Output: Real-time X-ray images for surgical/diagnostic guidance; image storage and PACS transmission. Benefits: Real-time anatomical visualization during interventional procedures; improved diagnostic workflow via digital archiving.
Clinical Evidence
No clinical studies performed. Evidence based on bench testing and comparative phantom image analysis. Anthropomorphic phantoms representative of indicated anatomies were imaged using subject and predicate devices; images reviewed by qualified clinical experts, confirming equivalent image quality.
Technological Characteristics
Mobile C-arm fluoroscopic system. Components: X-ray tube, flat panel detector, 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. Software: IEC 62304 compliant. Cybersecurity: ANSI UL 2900-1, IEC 81001-5-1.
Indications for Use
Indicated for patients requiring X-ray radiography or fluoroscopy during surgery or treatment, including emergency, orthopedic, neurosurgery, and bone surgery. Applicable to adults and pediatrics. 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
- VERADIUS UNITY (K142708)
Reference Devices
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
June 10, 2025
DRTECH Corporation
% Minjeong Kim
Official Correspondent
Suite No.1, 2 Floor /Suite No. 2, 3 Floor, 29, Dunchon-Daero
541 Beon-Gil, Jungwon-Gu
SEONGNAM-SI, GYEONGGI 13216
SOUTH KOREA
Re: K250010
Trade/Device Name: Extron 3; Extron 5; Extron 7
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, OXO, JAA
Dated: December 31, 2024
Received: May 9, 2025
Dear Minjeong 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K250010 - Minjeong Kim
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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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K250010 - Minjeong Kim
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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,
Digitally signed by Gabriela M. Rodal - 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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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.
Submission Number (if known)
K250010
Device Name
EXTRON 3;
EXTRON 5;
EXTRON 7
Indications for Use (Describe)
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.)
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.
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## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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K250010
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)]
12/31/2024
# 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: Minjeong Kim
- Telephone No.: +82-31-779-7783
- 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 5, EXTRON 7
- 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: | K142708 | K122234 | K230871 |
| Applicant: | PHILIPS MEDICAL SYSTEMS NETHRLANDS BV | GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC | DRTECH Corporation |
| Trade Name: | VERADIUS UNITY | OEC 9900 ELITE | EXTRON 5, EXTRON 7 |
| 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 3/5/7) with Predicate and Reference Devices
| Parameter | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- |
| 510(K) Number | K250010 | K142708 | K122234 | K230871 | - |
| Manufacturer | DRTECH Corporation | Philips Medical Systems Nederland B.V. | GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC | DRTECH Corporation | - |
| Model Name | EXTRON 3, EXTRON 5, EXTRON 7 | Veradius Unity | OEC 9900 ELITE | EXTRON 5, EXTRON 7 | - |
| 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 | | | | Equivalent |
| 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 | 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, | 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. | EXTRON5 and EXTRON 7 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 | Equivalent |
510(k) Summary
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DRTECH
| Parameter | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- |
| | 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.) | radiologists, and 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 | Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. | 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.) | |
| Target population | Patients who need X-ray radiography or fluoroscopy images
Adults and Pediatrics | Patients who need diagnostic, interventional and surgical procedures, except neonates (birth to one month) | Patients who need fluoroscopic and spot-film images | Patients who need X-ray radiography or fluoroscopy images
Adults and Pediatrics | Equivalent |
| Mobile Platform | Yes | Yes | Yes | Yes | Equivalent |
| X-ray tube | EXTRON 3 : Stationary Anode | Rotating Anode | Rotating Anode | Rotating Anode | Equivalent : X-ray tubes and |
510(k) Summary
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DRTECH
| Parameter | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- |
| | EXTRON 5 : Rotating Anode
EXTRON 7: Rotating Anode | | | | systems verified according to the IEC 60601-2-28 and IEC 60601-1 series meet strict international safety and performance standards. Therefore, differences in X-ray tubes do not raise new concerns regarding safety and effectiveness. |
| Radiographic Mode | 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 125mA | kV Range : 40 to 120kV mA Range : Up to 150mA | kV Range : 40 to 120kV mA Range : Up to 150mA
※ EXTRON 7 only | Equivalent : Alteration in the mA does not give rise to any novel concerns regarding safety and effectiveness. |
| Fluoroscopic Mode | 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 : 1 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 :
EXTRON 5 - Up to 40mA
EXTRON 7 - Up to 60mA | Equivalent : Alteration in the mA does not give rise to any novel concerns regarding safety and effectiveness. |
| Dimension | Immersion Depth
EXTRON 3 - 73cm
EXTRON 5 - 74cm
EXTRON 7 - 74cm
Free Space : 80cm
Orbital movement : 165° | Immersion Depth : 73cm
Free Space : 77cm
Orbital movement : 145° | Immersion Depth : 84cm
Free Space : 79cm
Orbital movement : 145° | Immersion Depth : 74cm
Free Space : 80cm
Orbital movement : 165° | 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 |
510(k) Summary
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DRTECH
| Parameter | | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | | | 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 2121P : 1500 x 1500 pixels
EXPD 2323P : 1536 x 1536 pixels
EXPD 2323PB:1536 x 1536 pixels
EXPD 3030P : 2048 x 2048 pixels | 1560 x 1420 pixels | 21 cm FPD : 1536 x 1496 pixels
31 cm FPD : 1548 x 1524 pixels | EXPD 2121P : 1500 x 1500 pixels
EXPD 3030P : 2048 x 2048 pixels | Equivalent : Alteration in the detector pixels do not give rise to any novel concerns regarding safety and effectiveness. |
| | DQE | 55% @1lp/mm | 70% @ 0p/mm | 21 cm FPD : Typical 63% @0.5lp/mm
31 cm FPD : Typical 62% @0.5lp/mm | 55% @1lp/mm | Equivalent : Similarly, while there is a difference in DQE values, the Subject Device demonstrated clinically comparable image quality to the Predicate and Reference Devices during clinical image comparison evaluations. Thus, no novel concerns regarding safety and effectiveness are introduced. |
| | MTF | 55% @1lp/mm | 59% @ 1lp/mm | - | 55% @1lp/mm | Equivalent : Although there is a difference in MTF values, actual clinical image comparison |
510(k) Summary
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510(k) Summary
7 / 9
# DRTECH
| Parameter | Subject Device | Predicate Device | Reference 1 | Reference 2 | Discussion |
| --- | --- | --- | --- | --- | --- |
| | | | | | evaluations
confirmed that the
Subject Device
provides image
resolution that is
equivalent to or better
than that of the
Predicate and
Reference Devices.
Therefore, this
difference does not
give rise to any novel
concerns regarding
safety and
effectiveness. |
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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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D R T E C H
IEC 81001-5-1 Edition 1.0 Health software and health IT systems safety, effectiveness and security 2021-12 - 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: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices | July 11, 2016 |
| 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, 2022 |
Sample clinical images using anthropomorphic phantoms representative of the indicated anatomies and populations have been taken for both the proposed devices (EXTRON 3/5/7) and the predicate devices (Veradius Unity and OEC 9900 ELITE). 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)]
Not Applicable
Clinical studies were not performed, but phantom 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 (Veradius Unity (K142708), EXTRON 5/7(K230871), OEC 9900 ELITE(K122234)) 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
