UC-5000 Mobile X-Ray

K163063 · Source-Ray, Inc. · IZL · Dec 12, 2016 · Radiology

Device Facts

• Record ID: K163063
• Device Name: UC-5000 Mobile X-Ray
• Applicant: Source-Ray, Inc.
• Product Code: IZL · Radiology
• Decision Date: Dec 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Indications for Use

The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammography.

Device Story

Mobile X-ray system for general purpose radiography; utilizes high-frequency 5.0 kW generator with closed-loop regulation. Inputs: AC power (115/220 VAC); operator-selected exposure parameters (kVp, mA, mAs, time). Outputs: X-ray radiation for image acquisition via film, computed radiography, or optional digital flat panel. Operated by healthcare professionals in clinical settings. Optional digital configuration includes ViZion DR wireless panel and Opal Rad imaging software on a TabletKiosk PC. System provides digital displays for exposure parameters; facilitates image preview, window/level adjustment, and DICOM storage/printing. Enhances clinical decision-making by providing rapid diagnostic imaging at the point of care.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including kVp/mA calibration, timer tests, mAs display, Half Value Layer, reproducibility, linearity, radiation leakage, and collimator alignment. Compliance with 21 CFR 1020.30/1020.31 and IEC standards verified. Optional digital imaging components validated via assembly and test images.

Technological Characteristics

High-frequency 5.0 kW generator (30 kHz); stationary anode X-ray tube (Tungsten target, 1.2 mm focal spot). 115/220 VAC power. Microprocessor control. Optional digital integration: 14x17 wireless amorphous silicon flat panel (150 micron pixel size). Standards: IEC 60601-1:2005, IEC 60601-1-2:2014, 21 CFR 1020.30/1020.31.

Indications for Use

Indicated for general purpose radiographic exams in patients requiring mobile X-ray imaging. Not indicated for mammography.

Regulatory Classification

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.

Predicate Devices

• PowerMax 1260 Portable X-Ray System (K090655)

Reference Devices

• ViZion DR Panel (K152279)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12, 2016

Source-Ray, Inc. % Daniel Kamm, P.E. President Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K163063

Trade/Device Name: UC-5000 Mobile X-ray Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL, MQB Dated: September 24, 2016 Received: November 2, 2016

Dear Mr. Kamm:

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

Robert Ochs, Ph.D. 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) K163063

Device Name UC-5000 Mobile X-Ray

Indications for Use (Describe)

The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammography.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary: 510(k) Number K163063

Image /page/3/Picture/1 description: The image shows the logo for Source-Ray, Inc. The logo features the letters "SRI" in a bold, sans-serif font, with the "I" having a red dot above it. Below the letters, the words "source-ray, inc." are written in a smaller, sans-serif font.

Source-Ray, Inc. 50 Fleetwood Court Ronkonkoma, NY 11779 [phone] Date Prepared: December 2, 2016 Contact: Ray Manez, President

- 1. Identification of the Device: Proprietary-Trade Name: UC-5000 Mobile X-Ray Classification Name: Mobile x-ray system Regulation Number: 21CFR §892. 1720, Regulation Name: Mobile x-ray system Regulatory Class: II Product Codes: IZL and MQB
- Equivalent legally marketed device: K090655, Trade/Device Name: PowerMax 1260 Portable X-2. Ray System, manufactured by Source-ray, Inc. Regulation Number: 21CFR §892. 1720, Regulation Name: Mobile x-ray system, Regulatory Class: II Product Code: IZL
- 3. Indications for Use (intended use): The UC-5000 Mobile X-Ray is intended for General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels. Not for mammography.
- Description of the Device: The UC-5000 Mobile X-Ray consists of an X-ray generator, continuously 4. adjustable light beam collimator, mounting arm, exposure cord with exposure switch, and AC power cord. This is a high-frequency generator of updated design. Light Weight (no batteries) No Special Power Requirements (115/220 VAC Power Input) High Frequency 5.0 kW Generator with Closed loop regulation Digital Displays: kVp, mA, mAs & exposure time. Optionally available with the system is an FDA cleared digital panel and software combination.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench testing, safety agency testing, risk analysis, and software validation indicates that the new device is as safe and effective as the predicate device. Proper system operation is fully verified upon installation.

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## 6. Substantial Equivalence Chart

| | K090655 Model PowerMax 1260<br>Portable X-Ray System | UC-5000 Mobile X-Ray |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Model PowerMax 1260 Portable<br>X-Ray System is intended for General<br>Purpose Portable Radiographic<br>Applications (Not for mammographic<br>use. Language later required by FDA) | The UC-5000 Mobile X-Ray is intended<br>for General Purpose Radiographic<br>exams utilizing film, computed<br>radiography, or direct digital flat panels.<br>Not for mammographic use. (Language<br>added for CR/DR) |
| Size / weight: | 110 lbs. / 50 kG | 340 lb., 154.2 KG |
| Energy Source: | 120/220 V 50 – 60 Hz AC | SAME |
| Use Interface: | Dedicated Touch Panel | SAME |
| Exposure times: | 0.01 - 3.33 sec | .01 - 5.00 sec |
| mA Range | 12.5-60 | 10 - 50 mA |
| Control | Microprocessor | SAME |
| HF Generator | 30 kHz | SAME |
| kW | 3 kW | 5.0 kW |
| kVp: | 40 - 120kVp 80 steps | 40 - 110kVp 41 steps |
| X-ray Tube | SXR-130-15-1.2; Stationary Anode<br>130 kVp Target Material Tungsten<br>Anode Capacity 45,000 HU Storage<br>Focal Spot 1.2 mm; Target Angle 15° | SAME |
| CR/DR<br>Compatible | YES | SAME, now available with OPTIONAL<br>computer, panel, and software<br>Flat Panel: ViZion DR Panel<br>14 x 17 Wireless, Viztek (K152279),<br>High Quality Wireless 14" X 17" Digital<br>Panel, Amorphous Silicon Scintillator<br>150 x 150 micron pixel size<br>Software: Opal Rad Imaging Software<br>Viztek also cleared in K152279.<br>Features:<br>Window / Level; Image Preview;<br>DICOM Print / Store; Fast Image<br>Processing; (image displayed within 3<br>seconds);<br>Computer: 20" All-In-One<br>Tabletkiosk PC (TAIO20T) with Touch |
| | K090655 Model PowerMax 1260<br>Portable X-Ray System | UC-5000 Mobile X-Ray |
| | | Screen |
| Collimator | Collimare Model CPL-125-UC01-C | SAME |
| | This device complies with all<br>applicable performance standards<br>under 21 CFR 1020.30 and 1020.31. | This device complies with all applicable<br>performance standards under 21 CFR<br>1020.30 and 1020.31. |
| Standards | IEC 60601-1: 2005 ANSI Medical<br>electrical equipment - Part 1: General<br>requirements for basic safety and<br>essential performance | SAME |
| | IEC 60601-1-2: 2014 Medical<br>electrical equipment - Part 1-2:<br>General requirements for basic safety<br>and essential performance - Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements and test | SAME |
| Photo | Image: Portable X-Ray System | Image: Mobile X-Ray |
| | K090655 Model PowerMax 1260<br>Portable X-Ray System | UC-5000 Mobile X-Ray |
| Digital Panel | Not specified | ViZion DR Panel, 14 x 17 Wireless,<br>Viztek (K152279)<br>Image: Vizion DR Panel |

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- 7. Summary of non-clinical testing: Software validation and risk analysis was performed. NRTL Laboratory testing was performed according to the following standards: IEC 60601-1 and IEC 60601-1-2. This device complies with all applicable performance standards under 21 CFR 1020.30 and 1020.31. Performance testing over the range of possible AC line voltages checked: kVp calibration at high and low ma; ma calibration at high and low ma; timer tests; mAs display; Half Value Layer; reproducibility; linearity; radiation leakage; collimator light illuminance and alignment; and x-ray field coverage. The optional digital imaging components were assembled, tested, and calibrated per the originally FDA cleared instructions provided by the original equipment manufacturers. Test images showed the generator + panel system performs as intended. A calibration procedure was written for the end user and was executed properly in our factory.
- 8. Summary of clinical testing: Not applicable. Clinical testing was not deemed to be required to show substantial equivalence. We relied on non-clinical testing and compliance with standards.
- 9. Conclusion: After analyzing software validation, bench tests, test images, and safety agency test reports, it is the conclusion of Source-ray, Inc. that the UC-5000 Mobile X-Ray is as safe and effective as the predicate device, has few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.