(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: 50~110kV (1kV step) | |||
| F5000: 50~110kV (1kV step) | Similar (Some models have wider range, some similar) | ||
| Difference Discussion: Similar or better performance | |||
| Tube current (mA) | 30mA (40-66kV), 20mA (68kV – 100kV) | F1600: 12~30mA | |
| F2400: 20~40mA | |||
| F2800: 14~40mA | |||
| F3200: 25~60mA | |||
| F4000: 20~80mA | |||
| F5000: 20~100mA | Varies by model, generally similar or higher capacity. | ||
| Difference Discussion: Similar or better performance | |||
| mAs | 0.3 mAs – 50 mAs | F1600: 0.4~32mAs | |
| F2400: 0.4~100mAs | |||
| F2800: 0.4~100mAs | |||
| F3200: 0.4~100mAs | |||
| F4000: 0.4~100mAs | |||
| F5000: 0.4~100mAs | 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.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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How the ground truth for the training set was established
- Not applicable.
§ 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.