(40 days)
No
The summary describes a standard mobile X-ray system with digital imaging capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Fast Image Processing" refers to the speed of displaying the image, not necessarily AI/ML-driven analysis.
No.
The device is described as an X-ray system intended for general purpose radiographic exams, which are diagnostic imaging procedures, not therapeutic ones.
No
The device is an X-ray system used for general radiographic exams, which captures images but does not interpret them to diagnose diseases or conditions.
No
The device description explicitly lists hardware components such as an X-ray generator, collimator, mounting arm, and exposure cord. While it mentions optional software, the core device is a physical X-ray system.
Based on the provided information, the UC-5000 Mobile X-Ray is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "General Purpose Radiographic exams utilizing film, computed radiography, or direct digital flat panels." This describes a device used for imaging the human body, not for testing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details components related to generating and controlling X-rays for imaging. There are no mentions of reagents, assays, or other components typically associated with IVD devices.
- Input Imaging Modality: The input modality is X-Ray, which is used for imaging the body directly, not for analyzing samples.
- Lack of IVD-specific information: The document does not contain any information related to the analysis of biological samples, which is the core function of an IVD device.
In summary, the UC-5000 Mobile X-Ray is a medical imaging device used for diagnostic purposes, but it operates by generating X-rays to create images of the body, not by performing tests on in vitro samples.
N/A
Intended Use / 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.
Product codes
IZL, MQB
Device Description
The UC-5000 Mobile X-Ray consists of an X-ray generator, continuously 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
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.
1
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. 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 (631) 244-8200 Date Prepared: December 2, 2016 Contact: Ray Manez, President
-
- 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
-
- 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.
-
- 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
Portable X-Ray System | UC-5000 Mobile X-Ray |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Model PowerMax 1260 Portable
X-Ray System is intended for General
Purpose Portable Radiographic
Applications (Not for mammographic
use. Language later required by FDA) | The UC-5000 Mobile X-Ray is intended
for General Purpose Radiographic
exams utilizing film, computed
radiography, or direct digital flat panels.
Not for mammographic use. (Language
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
130 kVp Target Material Tungsten
Anode Capacity 45,000 HU Storage
Focal Spot 1.2 mm; Target Angle 15° | SAME |
| CR/DR
Compatible | YES | SAME, now available with OPTIONAL
computer, panel, and software
Flat Panel: ViZion DR Panel
14 x 17 Wireless, Viztek (K152279),
High Quality Wireless 14" X 17" Digital
Panel, Amorphous Silicon Scintillator
150 x 150 micron pixel size
Software: Opal Rad Imaging Software
Viztek also cleared in K152279.
Features:
Window / Level; Image Preview;
DICOM Print / Store; Fast Image
Processing; (image displayed within 3
seconds);
Computer: 20" All-In-One
Tabletkiosk PC (TAIO20T) with Touch |
| | K090655 Model PowerMax 1260
Portable X-Ray System | UC-5000 Mobile X-Ray |
| | | Screen |
| Collimator | Collimare Model CPL-125-UC01-C | SAME |
| | This device complies with all
applicable performance standards
under 21 CFR 1020.30 and 1020.31. | This device complies with all applicable
performance standards under 21 CFR
1020.30 and 1020.31. |
| Standards | IEC 60601-1: 2005 ANSI Medical
electrical equipment - Part 1: General
requirements for basic safety and
essential performance | SAME |
| | IEC 60601-1-2: 2014 Medical
electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic
disturbances - Requirements and test | SAME |
| Photo | Image: Portable X-Ray System | Image: Mobile X-Ray |
| | K090655 Model PowerMax 1260
Portable X-Ray System | UC-5000 Mobile X-Ray |
| Digital Panel | Not specified | ViZion DR Panel, 14 x 17 Wireless,
Viztek (K152279)
Image: Vizion DR Panel |
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6
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- 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.
-
- 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.
-
- 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.