(95 days)
This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.
This product, portable X-ray generator, is radiation medical equipment which can only be used by professional radiologists. It controls and marks Xray dose within the range of X-ray exposure limited by hardware. Also it uses algorithm of X-ray output for processing and control. This portable Xray generator requires equipment for X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body used with a stand. And when attached to a stand, it is easy to adjust positioning for medical imaging.
Here's a breakdown of the acceptance criteria and study information for the EPX-Series Mobile X-ray System, based on the provided document:
This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific clinical acceptance criteria in the same way a de novo or PMA submission might.
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device (PORTA 100HF, K122697) by showing similar or improved technical characteristics and compliance with recognized safety standards. The table below summarizes the comparison presented.
| Characteristic | Acceptance Criteria (Predicate Device K122697) | Reported Device Performance (EPX-Series) | Met? |
|---|---|---|---|
| Intended Use | Diagnostic X-rays for adults and pediatric subjects on various body parts. | Diagnostic X-rays for adults and pediatric subjects on hand, foot, shoulder, elbow, knee, and other body parts. | Yes |
| Energy Source | 100V-120V or 200V-240V Single 50/60 Hz | 110V | Yes |
| User Interface | Up and down Rotary switch for kV and mAs value with 7 segment LED | Up and down Rotary switch for kV and mAs value with 7 segment LED | Yes |
| Exposure switch | Dual stage, deadman type with curled cable. | Dual stage, deadman type with curled cable. | Yes |
| Controls | Software based | Software based | Yes |
| Construction | Monobloc HF generator, Medical full bridge inverter system | Monobloc HF generator, Medical full bridge inverter system | Yes |
| High Voltage Adjustment | High frequency inverter | High frequency inverter | Yes |
| Line Voltage Adjustment | Automatic, Dynamic | Automatic, Dynamic | Yes |
| Exposure times (sec) | 0.01 - 2.50 sec, 32 steps | F1600: 0.01-2.46 sec, 20 steps F2400: 0.01-4.0 sec, 25 steps F2800: 0.01-3.57 sec, 25 steps F3200: 0.01-3.2 sec, 25 steps F4000: 0.01-4.0 sec, 25 steps F5000: 0.01-5.0 sec, 25 steps | Similar (Some models have higher range, some similar)Difference Discussion: Similar or better performance |
| Tube Potential (kV) | 40-100kV (2kV step) | F1600: 40-90kV (1kV step) F2400: 40-100kV (1kV step) F2800: 40-120kV (1kV step) F3200: 40-100kV (1kV step) F4000: 50 | Similar (Some models have wider range, some similar)Difference Discussion: Similar or better performance |
| Tube current (mA) | 30mA (40-66kV), 20mA (68kV – 100kV) | F1600: 12 | Varies by model, generally similar or higher capacity.Difference Discussion: Similar or better performance |
| mAs | 0.3 mAs – 50 mAs | F1600: 0.4 | Varies by model, generally similar or higher capacity.Difference Discussion: similar or better performance |
| X-ray tube | Toshiba D-124 | F1600, F2400, F2800: D-125 F3200: D-205B F4000, F5000: OX/110-15 | Different models, but acceptable for function.Difference Discussion: No additional risk concerns |
| Anode heat storage | 20K HU | F1600, F2400, F2800: 50K HU F3200: 40k HU F4000, F5000: 42k HU | Higher/better.Difference Discussion: Larger anode heat storage is a safety benefit |
| Focal Spot | 1.2mm | F1600, F2400, F2800: 1.2mm F3200: 2.0mm F4000, F5000: 1.8mm | Similar or larger.Difference Discussion: Larger focal spot results in wider useful beam, no additional risk concerns |
| Total Filtration | 2.5mm AL. eq. at 100kV | F1600, F2400, F2800, F3200: 3.3mm AL.Eq@75kV F4000, F5000: 3mm AL.Eq@75kV | Similar or better (higher filtration reduces patient dose).Difference Discussion: Reduces patient radiation dose |
| Collimator | Complete with 30 sec. timer and cross indication line | Complete with 30 sec. timer and cross indication line | Yes |
| Performance Standard | 21CFR 1020.30 | 21CFR 1020.30 | Yes |
| Electrical Safety | IEC 60601-1; IEC 60601-1-3; IEC 60601-2-28; IEC 60601-1-2; IEC 60601-2-7; IEC 60601-2-54 | IEC 60601-1; IEC 60601-1-3; IEC 60601-2-28; IEC 60601-1-2; IEC 60601-2-54 (Note: IEC 60601-2-7 replaced by IEC 60601-1 3rd Ed.) | Yes (Updated standard compliance)Difference Discussion: IEC 60601-2-7 withdrawn and replaced |
| X-ray Radiography | Conventional X-ray film or digital imaging detector | Conventional X-ray film or digital imaging detector | Yes |
Study Details:
This submission relies on non-clinical testing to demonstrate substantial equivalence, not a clinical study to prove device performance against specific clinical acceptance criteria or human reader improvement.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set of images/patients is described. The "test set" for this type of submission refers to the physical device and its components undergoing engineering and safety testing.
- Provenance: The device manufacturer (ECOTRON Co., Ltd.) is located in Seoul, Korea. The testing labs are mentioned as "3rd party testing lab A" and "In-house Test Report A." No further details on geographic location or specific data provenance for the non-clinical tests are provided.
- Retrospective/Prospective: Not applicable to the non-clinical testing described.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As this is a non-clinical performance and safety assessment for substantial equivalence, clinical ground truth established by medical experts for image interpretation is not part of this specific submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or subjective assessment requiring adjudication is mentioned.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC or comparative effectiveness study was performed or cited. This device is a basic X-ray system, not an AI-powered diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is an X-ray hardware system, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" is defined by recognized international and FDA standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, FDA EPRC Performance Standard 21 CFR 1020.30 and 31, and ISO 14971 (Risk Management).
-
The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/ML device.
-
How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
ECOTRON Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K151038
Trade/Device Name: EPX-Series Mobile X-ray System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: June 19, 2015 Received: June 25, 2015
Dear Mr. 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 (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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151038
Device Name Epx-series Mobile X-ray System
Indications for Use (Describe)
This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.
| 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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Image /page/3/Picture/0 description: The image is a logo for a company called "ecoTRON." The logo has a blue square with three vertical lines on the left side. To the right of the square is the text "eco & electronics" in a smaller font. Below the square and text is the word "ecoTRON" in a larger font, with "eco" in blue and "TRON" in gray.
EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000
SECTION 07
510(k) SUMMARY
SECTION 07 Page 1 / 8
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Image /page/4/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black font and is located above the word "eddTRON". The word "eddTRON" is in a gray font.
1. Traditional 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.
Date 510K summary prepared : April 10, 2015
Submitter's Name, address, telephone number, a contact person:
| Submitter's Name : | ECOTRON Co, Ltd. |
|---|---|
| Submitter's Address: | Rm 504, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-gu, Seoul, Korea |
| Submitter's Telephone: | Tel:+82-2-2025-3760 / Fax:+82-2-2025-3764 |
| Contact person: | Mr. Sang Bong Lee / RA Assist Mgr |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| Address: | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone: | +713-467-2607 |
| Fax: | +713-583-8988 |
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Trade/proprietary name: | EPX Series Mobile X-ray SystemF1600, F2400, F2800, F3200, F4000, F5000 |
|---|---|
| Regulation Name: | Mobile X-ray System |
| Regulation Number: | 21 CFR 892.1720 |
| Regulatory Class: | II |
| Product Code: | IZL |
| Predicate DeviceManufacturer: | JOB Corporation |
| Device: | PORTA 100HF |
| 510(k) Number: | K122697 |
| Decision Date: | Oct. 5, 2012 |
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Image /page/5/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo features a series of blue squares on the left, followed by the text "eco & electronics" in a smaller font. Below this, the word "eddTRON" is displayed in a larger, gray font.
2. Device Description
This product, portable X-ray generator, is radiation medical equipment which can only be used by professional radiologists. It controls and marks Xray dose within the range of X-ray exposure limited by hardware. Also it uses algorithm of X-ray output for processing and control. This portable Xray generator requires equipment for X-ray images. Small in size, this product is convenient to carry with, and suitable for being moved around. The main body used with a stand. And when attached to a stand, it is easy to adjust positioning for medical imaging.
3. Indications for Use
This rroduct, diagnostic X-ray system, is radiation ment used by a qualified / trained physician or technician on both adult and pediatric subjects for taking diagnostic X-rays.
This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.
4. Summary of Design Control Risk management
EPX mobile X-ray series have been developed to provide the mobility of X-ray users to patients while meeting the critical functional requirements and international safety standards The risks and the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase were reviewed and implemented in the new product design phase. The overal assessment concluded that all risks and hazardous conditions identified arising from the design and production were successfully mitigated and accepted.
5. Summary of the technological characteristics of the device compared to the predicate device:
EPX mobile X-ray series escribed in this 510(k) have the similar indications for use and technical characteristics as the predicate device, PORTA 100HF (K122697) manufactured by JOB Corporation.
6. Substantial Equivalence
EPX Series mobile X-ray system conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to electro-, mechanical-, clinical-, and risk management, it is confirmed that EPX Series is substantially equivalent to the predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for "eco & electronics eddTRON". The logo features a blue square design on the left, followed by the text "eco & electronics" in black. Below this, the word "eddTRON" is displayed in a larger, gray font, creating a visually distinct and modern brand identity.
| Characteristics | EPX series Mobile X-ray System(F1600, F2400, F2800, F3200, F4000, F5000) | PORTA 100HF (K122697) , JOBCorporation | SE-# | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Intended Use | This product, diagnostic X-ray system, is radiation medical equipment used bya qualified / trained physician or technician on both adult and pediatric subjectsfor taking diagnostic X-rays.This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, andother body parts. | Intended use by aqualified/technician on both adult and pediatric subjects for takingdiagnostic X-rays | Similar | ||||||
| Energy Source | 110V | 100V-120V or 200V-240VSingle 50/60 Hz | Same | ||||||
| User Interface | Up and down Rotary switch for kV and mAs value with 7 segment LED | Up and down Rotary switch for kVand mAs value with 7 segmentLED | Same | ||||||
| Exposure switch | Dual stage, deadman type with curled cable. | Dual stage, deadman type withcurled cable. | Same | ||||||
| Controls | Software based | Software based | Same | ||||||
| Construction | Monobloc HF generator, Medical full bridge inverter system | Monobloc HF generator, Medicalfull bridge inverter system | Same | ||||||
| High VoltageAdjustment | High frequency inverter | High frequency inverter | Same | ||||||
| Line VoltageAdjustment | Automatic, Dynamic | Automatic, Dynamic | Same | ||||||
| Exposure times | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 0.01 - 2.50 sec, 32 steps | ||
| (sec) | 0.01~2.46sec,20steps | 0.01-4.0sec,25steps | 0.01-3.57sec,25steps | 0.01-3.2sec,25steps | 0.01-4.0sec,25steps | 0.01-5.0sec,25steps | Similar | ||
| Tube Potential | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 40-100kV (2kV step) | Similar | |
| (kV) | 40-90kV(1kV step) | 40-100kV(1kV step) | 40-120kV(1kV step) | 40-100kV(1kV step) | 50~110kV(1kV step) | 50~110kV(1kV step) | |||
| Tube current | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 30mA (40-66kV)20mA (68kV – 100kV) | #1 | |
| 12~30mA | 20~40mA | 14~40mA | 25~60mA | 20~80mA | 20~100mA | ||||
| F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | ||||
| mAs | 0.4~32mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.4~100mAs | 0.3 mAs – 50 mAs | #2 | |
| X-ray tube | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | Toshiba D-124 | #3 | |
| D-125 | D-125 | D-125 | D-205B | OX/110-15 | OX/110-15 | ||||
| Anode heatstorage | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 20K HU | #4 | |
| 50K HU | 50K HU | 50K HU | 40k HU | 42k HU | 42k HU | ||||
| Focal Spot | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | 1.2mm | #5 | |
| 1.2mm | 1.2mm | 1.2mm | 2.0mm | 1.8mm | 1.8mm | ||||
| Total Filtration | F1600 | F2400 | F2800 | F3200 | F4000 | F5000 | |||
| 3.3mm AL.Eq@75kV | 3.3mm ALEq@75kV | 3.3mm ALEq@75kV | 3.3mm ALEq@75kV | 3mm ALEq@75kV | 3mm ALEq@75kV | 2.5mm AL. eq. at 100kV | #6 | ||
| Collimator | Complete with 30 sec. timer and cross indication line | Complete with 30 sec. timer andcross indication line | Same | ||||||
| PerformanceStandard | 21CFR 1020.30 | 21CFR 1020.30 | same | ||||||
| Electrical Safety | IEC 60601-1:IEC 60601-1-3IEC 60601-2-28IEC 60601-1-2IEC 60601-2-54 | IEC 60601-1:IEC 60601-1-3IEC 60601-2-28IEC 60601-1-2IEC 60601-2-7IEC 60601-2-54 | #7 | ||||||
| X-ray Radiography | Conventional X-ray film or digital imaging detector | Conventional X-ray film or digitalimaging detector | same |
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Image /page/7/Picture/0 description: The image shows the logo for eco & electronics edotron. The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black and is located on the top right side of the logo. The text "edoTRON" is in gray and is located on the bottom right side of the logo.
EPX Series Diagnostic X-ray System:
F1600, F2400, F2800, F3200, F4000, F5000
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Image /page/8/Picture/0 description: The image is a logo for "eco & electronics edoTRON". The logo has a blue icon on the left, followed by the text "eco & electronics" in black. Below that is the word "edoTRON", with "edo" in blue and "TRON" in gray. The logo is simple and modern, with a focus on the company's name and its connection to electronics.
7. Difference Discussion
| SE-# | SE discussion |
|---|---|
| SE-#1, #2, | EPX Series mobile X-ray system performs similar or better compared to the predicate device in terms of performancespecifications. For EPX-F1600, the performance specification is almost identical to the predicate device In termsof kV, tube current. EPX-F1600 provides more segmented kV step control compared to the predicate.EPX-F2400and EPX-F2800 have similar or higher capacity than the predicate device in terms of KV and tube current settingwhich may require shorter patient exposure time.EPX-F3200, EPX-4000 and EPX-F5000 are equipped with even higher performance specifications and higher tubecurrent control is possible. The high voltage controls X-ray penetration and thus the image. Thetube current and exposure time affect the dose and therefore the darkness of the image.Such differences in performance do not raise additional risk concerns. |
| SE-#3, #4, #5 | F1600, F2400, and F2800 show the same effective focal spot. The effective focal spot for F3200, F4000, andF5000 is larger than the predicate device. The effective focal spot size is controlled by the size of the actual focalspot and the anode target angle. Larger effective focal spot results wider useful beam. EPX series has largeranode heat storage than the predicate device. It refers to the capacity of the thermal energy of which the X-raytube must be able to support and dissipate during and after an exam. |
| SE-#6 | The minimum filtration reduces patient radiation dose by eliminating low energy that would otherwise beabsorbed by the patient's skin.Positive means are determined through linear interpolation to provide that at least the minimum filtration neededto achieve the above beam quality requirements is in the useful beam during each exposure, according to the HVLprovisions of 1020.30(m)(1). |
| SE-# 7 | IEC 60601-2-7 is withdrawn and replaced with IEC 60601-1 3rd Ed. |
8. Summary of the technological characteristics of the device compared to the predicate device:
The indications for use, mechanical components, performances and safety characteristics of EPX mobile X-ray series described in this 510(() are similar to those of the predicate device.
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Image /page/9/Picture/0 description: The image is a logo for "eco & electronics eddoTRON". The logo features a series of blue squares on the left side, followed by the text "eco & electronics" in a smaller font size. Below this text is the word "eddoTRON" in a larger, bolder font. The color of "eddoTRON" is gray.
EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000
The primary differences are the specifications of X-ray generator of the subject device. The performance specifications of the subject device are similar or higher than that of the such as the X-ray generator and X-ray tube ande heat content (Heating Unit),
These differences do not have an effect on safety and effectiveness compared to the predicate device.
9. Performance Testing/Data
Testing for verfication and validation of the device was found acceptable to substantial equivalence. Safety compliance checking (including EMC, and so on) was evaluated according to the IEC Standards. ECOTRON Co., Ltd certifies conformance to Voluntary Standards covering electrical and Mechanical safety. In conclusion is of electrical hazards was mitiqated and is substantially equivalent of the predicate device in terms of safety and effectiveness.
10. Description of non-clinical tests.
EPX series diagnostic X-ray system has been tested for electromagnetic compatibility (IEC 60601-1-2, IEC 60601-2-54, IEC 60601-1-3, IEC 60601-2-28, and IEC 60601-1:2005.) The device also complies with FDA EPRC Performance Standard: 21 CFR 1020.30 and 31. The software validation and verification was also performed. The results of nonclinical testing indicate that the EPX series mobile X-ray system is as safe and effective as the predicate device.
Compliance evidences were submitted for the following standards:
- IEC 60601-1: Test Report issued by 3rd party testing lab A
- IEC 60601-1-2: Test Report issued by 3rd party testing lab A
- IEC 60601-1-3: Test Report issued by 3rd party testing lab A
- IEC 60601-2-54: Test Report issued by 3rd party testing lab A
- EPRC Standard: 21 CFR 1020.30 and 31: In-house Test Report A
- ISO 14971: Risk management file A
11. Description of clinical tests.
No cinical data is necessary to effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness.
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Image /page/10/Picture/0 description: The image shows the logo for "eco & electronics eddoTRON". The logo features a blue square design on the left, followed by the text "eco & electronics" in a smaller font size. Below this text is the word "eddoTRON" in a larger, bold font, with the "eddo" part in blue and the "TRON" part in gray. The overall design is clean and modern.
EPX Series Diagnostic X-ray System: F1600, F2400, F2800, F3200, F4000, F5000
12. Conclusion as to Substantial Equivalence
EPX SERIES are substantially equivalent to the predicate device PORTA 100 HF (K122697). These 2 devices are very similar in the intended use, the design principle, the perfornance and the applicable standards. Some characteristics, for exer interfaces and the capacity of X-ray generator and X-ray tube are different. However the compliance demonstrations and description of nonclinical review result in this submission that these differences do not raise any new questions of safety and effectiveness. Therefore, ECOTRON CO., LTD. concludes EPX series of mobile X-ray system are substantially equivalent with the predicate device PORTA 100 HF (K122697) of JOB Corporation.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.