(148 days)
Europa (Alternative: AiRTouch) portable X-ray system is intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric(over 12 years old) patients. These images are obtained using anatomical structures captured by film or image processing systems (workstation) after an examination involving radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use.
EUROPA(Alternative: AiRTouch) portable X-ray System generates X-ray with variable tube current and voltage (kVp) to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithium-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single portable X-ray enclosure. EUROPA(Alternative: AiRTouch) portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting device, and a remote-control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates patients' extremities and makes x-ray images on receptor. EUROPA(Alternative: AiRTouch) Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric(over 12 years old) patients.
EUROPA(Alternative: AiRTouch) portable X-ray is intended to be mounted on a tripod stand.
The provided FDA 510(k) clearance letter for the Europa Portable X-ray System is primarily a regulatory document affirming substantial equivalence to a predicate device. It details the device's technical specifications and how they compare to the predicate, as well as the non-clinical testing performed to meet electrical safety and radiation protection standards.
However, the document does NOT contain the information typically found in a study proving a device meets acceptance criteria related to its diagnostic performance (e.g., accuracy, sensitivity, specificity, or human perception improvement with AI assistance). The "clinical images" mentioned appear to be for general image quality assessment, not a structured clinical study with quantifiable metrics against defined acceptance criteria.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria and a study proving the device meets performance acceptance criteria. The document focuses on showing the device is substantially equivalent to a predicate device based on its technical specifications and adherence to safety and performance standards for X-ray equipment.
The relevant section related to "performance" in this document refers to:
- Non-clinical testing: Adherence to various IEC and CFR standards related to electrical safety, electromagnetic disturbances, radiation protection, and X-ray tube assemblies.
- "Clinical images" assessment: A qualitative statement that "Clinical images taken with EUROPA 85 and EUROPA 90 have presented overall appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities." This is not a quantitative performance study.
To answer your request based solely on the provided text, the following points are all "Not Provided" or "Not Applicable" because the document is a regulatory clearance letter focused on substantial equivalence rather than a detailed performance study report.
Summary of Device Acceptance Criteria and Performance (Based on the provided K244049 document):
The provided document, an FDA 510(k) clearance letter, primarily serves to demonstrate that the Europa (Alternative: AiRTouch) Portable X-ray System is substantially equivalent to a predicate device (EZER Portable X-ray System, K193535). The "acceptance criteria" discussed are largely related to technical specifications, electrical safety, radiation performance, and adherence to recognized standards, rather than a specific clinical performance study measuring diagnostic accuracy or reader improvement.
No clinical study details regarding diagnostic performance metrics (e.g., sensitivity, specificity, AUC) are provided in this document. The "clinical images" mentioned appear to have been part of a qualitative assessment of overall image quality for regulatory submission, not a formal quantitative performance study.
Detailed Breakdown of Requested Information:
| Feature | Description (Based on Provided Document) |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Acceptance Criteria (Implicit/Inferred from Non-Clinical Testing): |
| - Compliance with IEC 60601-1 (Basic safety & essential performance) | |
| - Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | |
| - Compliance with IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment) | |
| - Compliance with IEC 60601-2-28 (X-ray tube assemblies) | |
| - Compliance with IEC 60601-2-54 (X-ray equipment for radiography and radioscopy) | |
| - Compliance with IEC 62133 (Secondary cells and batteries safety) | |
| - Compliance with 21 CFR 1020 Subchapter J (Performance Standards for Ionizing Radiation Emitting Products), 21 CFR 1020.30 (Diagnostic x-ray system and their major components), and 21 CFR 1020.31 (Radiographic Equipment). | |
| - Qualitatively "appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities" (for clinical images taken with EUROPA 85 and EUROPA 90). | |
| Reported Device Performance (against the above): | |
| - "Testing was performed successfully according to the following standards:" (followed by the list above). | |
| - "Clinical images taken with EUROPA 85 and EUROPA 90 have presented overall appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities." | |
| - "Performance evaluation (test) reports and the device inspection report confirmed that the EUROPA(Alternative: AiRTouch) Portable X-ray Systems are suitable for its intended use and the instructions for use." | |
| 2. Sample size and data provenance (test set) | Not Provided. The document mentions "Clinical images taken," but does not specify the sample size (number of images, number of patients), or their provenance (country of origin, retrospective/prospective collection method). It's likely these were internal test images for qualitative assessment. |
| 3. Number/Qualifications of experts for ground truth | Not Provided. No details on experts used for "ground truth" (if any beyond qualitative assessment by internal personnel) are given. |
| 4. Adjudication method for test set | Not Provided. Since no formal clinical performance study with clear "ground truth" establishment is detailed, no adjudication method is mentioned. |
| 5. MRMC comparative effectiveness study? Effect size? | Not Applicable/Not Provided. The device is an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant to this type of device based on the information provided. |
| 6. Standalone (algorithm only) performance? | Not Applicable. This is a hardware X-ray system, not a diagnostic algorithm. Therefore, "standalone" performance in the sense of an algorithm operating independently is not relevant. The performance is the device's ability to produce quality X-ray images. |
| 7. Type of ground truth used | Implicit/Qualitative. For the image quality assessment, the "ground truth" seems to be a qualitative judgment by evaluators that the images showed "appropriate image quality of the anatomical structures." There is no mention of pathology, clinical outcomes, or expert consensus in a formal, quantifiable sense. For the safety and performance standards (IEC/CFR), the ground truth is adherence to the specified technical parameters and safety limits defined by those standards. |
| 8. Sample size for training set | Not Applicable. This document describes an X-ray system, not an AI/Machine Learning model that would typically have a "training set" for an algorithm. |
| 9. How ground truth for training set was established | Not Applicable. As above, no AI/ML model is described, so no training set or its associated ground truth establishment process is relevant to this document. |
FDA 510(k) Clearance Letter - Europa Portable X-ray System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 28, 2025
Livermoretech Inc
℅ Dave Kim
Medical Device Regulatory Affairs
Mtech Group LLC
7505 Fannin St. Suite 610
HOUSTON, TX 77054
Re: K244049
Trade/Device Name: Europa (Alternative: AiRTouch) portable X-ray system
Regulation Number: 21 CFR 892.1720
Regulation Name: Mobile X-Ray System
Regulatory Class: Class II
Product Code: IZL
Dated: April 29, 2025
Received: April 29, 2025
Dear Dave 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.
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K244049 - Dave Kim Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality 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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K244049 - Dave Kim Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Gabriela M. Rodal -S 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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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K244049
Device Name: Europa (Alternative: AiRTouch) portable X-ray system
Indications for Use (Describe):
Europa (Alternative: AiRTouch) portable X-ray system is intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric(over 12 years old) patients. These images are obtained using anatomical structures captured by film or image processing systems (workstation) after an examination involving radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use.
Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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801 North Jupiter Rd, Suite 200, Plano, TX 70574 USA
Tel.: +214-257-0113
510(k) Summary
K244049
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: April 23, 2025
I. SUBMITTER
Submitter's Name: Livermoretech Inc.
Submitter's Address: 801 North Jupiter Rd, Suite 200
Plano TX 75074
Submitter's Telephone
Contact person: Casey Lee (casey.lee@aspenimaging.com) / VP Manager Tel: +1-214-257-0113
Official Correspondent: Dave Kim, MBA (davekim@mtechgroupllc.com)
Mtech Group LLC
Address: 7505 Fannin St. Ste 610, Houston, TX 77054
Telephone: +713-467-2607
II. DEVICE
Trade/proprietary Name: Europa (Alternative: AiRTouch) Portable X-ray System
Model Name: Europa 85,85L, 90, 90L (Alternative: AiRTouch 855, 855L, 905, 905L)
Regulation Name: Mobile X-ray System
Regulation Number: 21 CFR 892.1720
Product Code: IZL
Regulatory Class: Class II
III. PREDICATE DEVICE
510K Number: K193535
Manufacturer: Livermoretech Inc.
Device Name: EZER Portable X-ray System
Regulation Name: Mobile X-ray System
Regulation Number: 21 CFR 892.1720
Product Code: IZL
Regulatory Class: Class II
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Tel.: +214-257-0113
IV. DEVICE DESCRIPTION:
EUROPA(Alternative: AiRTouch) portable X-ray System generates X-ray with variable tube current and voltage (kVp) to take diagnostic X-rays of extremities for adult and pediatric patients. It operates on 22.2VDC supplied by a rechargeable Lithium-Ion Polymer battery pack. The X-ray tube head, X-ray controls and power source are assembled into a single portable X-ray enclosure. EUROPA(Alternative: AiRTouch) portable X-ray System includes high voltage generator, X-ray tube, a control board (PCB), rechargeable battery, LCD user interface, X-ray beam limiting device, and a remote-control switch (hand switch). Operating principle is that x-ray generated by high voltage electricity into x-ray tube, which penetrates patients' extremities and makes x-ray images on receptor. EUROPA(Alternative: AiRTouch) Portable X-ray System is intended to be used by trained clinicians or technicians for both adult and pediatric(over 12 years old) patients.
EUROPA(Alternative: AiRTouch) portable X-ray is intended to be mounted on a tripod stand.
V. Indications for Use: 21 CFR 807 92 (a) (5)
Europa (Alternative: AiRTouch) portable X-ray system is intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric(over 12 years old) patients. These images are obtained using anatomical structures captured by film or image processing systems (workstation) after an examination involving radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use.
Comparison Table with the Predicate Device for technological characteristics:
| Feature | Europa (Alternative: AiRTouch) Portable X-ray System | EZER Portable X-ray System |
|---|---|---|
| 510K No | K244049 | K193535 |
| Indications for Use/Intended Use: | Europa(Alternative: AiRTouch) portable X-ray system is intended for use by trained or qualified doctors to produce diagnostic X-ray images of extremities in adult and pediatric(over 12 years old) patients. These images are obtained using anatomical structures captured by film or image processing systems (workstation) after an examination involving radiation exposure with cassette IP, CR, or DR (portable flat panel). Only intended for stand-mounted use. | EZER Portable X-Ray system is a portable x-ray source with a fixed tube current and voltage for producing diagnostic x-ray images of extremities using digital or film image receptors. Its use is intended to be used by trained clinician or technicians for both adult and pediatric subjects age 2 and above. It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for difference exam types. |
| Principle of Operation | General Purpose Diagnostic X-Ray | General Purpose Diagnostic X Ray |
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801 North Jupiter Rd, Suite 200, Plano, TX 70574 USA
Tel.: +214-257-0113
TECHNOLOGICAL:
| Feature | Europa (Alternative: AiRTouch) Portable X-ray System | EZER Portable X-ray System |
|---|---|---|
| Size: Body | Europa 85 (Alternative: AiRTouch 855): 266mm (W) x 167mm (H) x 156mm (D)Europa 85L (Alternative: AiRTouch 855L): 266mm (W) x 167mm (H) x 156mm (D)Europa 90 (Alternative: AiRTouch 905): 367mm (W) x 201mm (H) x 188mm (D)Europa 90L (Alternative: AiRTouch 905L): 293.5mm (W) x171mm (H) x160.5mm (D) | 9.2" L x 6.4"W x 4.6" H |
| Weight | Europa 85 (Alternative: AiRTouch 855): 3.61kgEuropa 85L (Alternative: AiRTouch 855L): 3.5kgEuropa 90 (Alternative: AiRTouch 905): 4.9kgEuropa 90L (Alternative: AiRTouch 905L): 3.7kg | 2.6kg (5.7 lbs.) |
| Source to skin distance | 30 cm | 30 cm |
| Focal Spot | Europa 85 (Alternative: AiRTouch 855): 0.8mmEuropa 85L (Alternative: AiRTouch 855L): 0.8mmEuropa 90 (Alternative: AiRTouch 905): 0.5mmEuropa 90L (Alternative: AiRTouch 905L): 0.5mm | 1.2 mm |
| Collimator | Double slit type, manually operated steplessly adjustable shutters | Four manually and steplessly adjustable shutters with light beam type central x-ray indicator (Advantech R72) |
| Triggering Mechanism | Two stage triggering | Two stage triggering |
| User Interface | Up-down push buttons for kVp selections and exposure time selections with LED indicators and mAs indicators. | Up-down push buttons for kVp selections and exposure time selections with LED indicators and mAs indicators. |
| Energy Source | Rechargeable 22.2 V DC, 2200mAh Lithium Ion Polymer battery pack | Rechargeable 22.2 V DC Lithium Ion Polymer battery pack |
| Exposure Time | Europa 85 (Alternative: AiRTouch 855): 0.03 ~ 2.0 Sec. (0.01 step) | 0.03~1.30 seconds in 0.01 increments |
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Tel.: +214-257-0113
| Feature | Europa (Alternative: AiRTouch) Portable X-ray System | EZER Portable X-ray System |
|---|---|---|
| Exposure Time (continued) | Europa 85L (Alternative: AiRTouch 855L): 0.03 ~ 2.0 Sec. (0.01 step)Europa 90 (Alternative: AiRTouch 905): 0.04 ~ 1.3 Sec. (0.01 step)Europa 90L (Alternative: AiRTouch 905L): 0.04 ~ 1.3 Sec. (0.01 step) | |
| mA | Europa 85 (Alternative: AiRTouch 855): 2 | 2.0 mA fixed |
| kVp | Europa 85 (Alternative: AiRTouch 855): 50 | 60 kVp fixed |
VI. Discussion of differences
The subject device is similar to the predicate device in terms of the indications for use and technological application. Both the subject and predicate devices are portable X-ray system for taking diagnostic X-rays of patients' extremities.
The subject device enables the user to select the power and exposure time manually whereas the power settings of the predicate device are fixed. Other differences include device design such as battery pack, exposure time, size and user interface.
VII. Summary of Clinical and Non-clinical testing
Testing was performed successfully according to the following standards:
- IEC 60601-1: 2020, Ed 3.2, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2020, Ed 4.1 IEC 60601-1-3:2008+A1:2013 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
- IEC 60601-1-3: 2021, Ed 2.2, Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
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- IEC 60601-2-28: 2017, Ed 3.0, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC 60601-2-54:2022, Ed 2.0 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC 62133:2012, Ed 2.0, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
Clinical images taken with EUROPA 85 and EUROPA 90 have presented overall appropriate image quality of the anatomical structures, both bony and soft tissues of the upper and lower extremities.
Furthermore, the following Specific Guidance Document was utilized in the device development to ensure the safety of this device for both the operators and patients:
- "Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use"
- "The Content of Premarket Submissions for Software Contained in Medical Devices"
- "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"
The device also conforms to the following:
- 21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products
- 21 CFR 1020.30: Diagnostic x-ray system and their major components
- 21 CFR 1020.31: Radiographic Equipment
VIII. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided above comparison table, the EUROPA(Alternative: AiRTouch) Portable X-ray Systems have little difference with its size and user interface as the information in the table.
The subject device is substantially equivalent to the predicate device with its intended use, mechanical and electrical performance as described.
Performance evaluation (test) reports and the device inspection report confirmed that the EUROPA(Alternative: AiRTouch) Portable X-ray Systems are suitable for its intended use and the instructions for use.
§ 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.