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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a mobile X-ray system (UC-5000 Mobile X-Ray) and seeks to prove its substantial equivalence to a predicate device (PowerMax 1260 Portable X-Ray System). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving absolute performance or clinical efficacy against specific disease outcomes.

Therefore, the "acceptance criteria" and "study" described are focused on proving substantial equivalence to the predicate device, not on meeting specific performance metrics for an AI algorithm or clinical diagnosis. The information provided is primarily related to the device's technical specifications and compliance with safety standards.

Let's address each point based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are implicitly related to demonstrating that the UC-5000 is substantially equivalent to the predicate device (PowerMax 1260 Portable X-Ray System) in terms of safety and effectiveness, and that its technical specifications are comparable or improved within acceptable limits without raising new questions of safety or effectiveness.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (UC-5000 Mobile X-Ray)	Comparison to Predicate (K090655 Model PowerMax 1260)
Intended Use (Same as predicate)	"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)	Similar, with added explicit mention of CR/DR compatibility ("Language added for CR/DR" on the UC-5000 side vs. "Not for mammographic use. Language later required by FDA" on the predicate). Both are for "General Purpose Radiographic applications."
Energy Source (Same as predicate)	"SAME" (120/220 V 50 – 60 Hz AC)	Identical
User Interface (Same as predicate)	"SAME" (Dedicated Touch Panel)	Identical
Control (Same as predicate)	"SAME" (Microprocessor)	Identical
HF Generator (Same as predicate)	"SAME" (30 kHz)	Identical
X-ray Tube (Same as predicate)	"SAME" (SXR-130-15-1.2; Stationary Anode, 130 kVp, Tungsten Target Material, 45,000 HU Storage Anode Capacity, 1.2 mm Focal Spot, 15° Target Angle)	Identical
Collimator (Same as predicate)	"SAME" (Collimare Model CPL-125-UC01-C)	Identical
Compliance with Performance Standards	"This device complies with all applicable performance standards under 21 CFR 1020.30 and 1020.31."	Identical claim for both predicate and new device regarding 21 CFR 1020.30 and 1020.31.
Compliance with Safety Standards	"IEC 60601-1: 2005 ANSI Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", "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"	Both predicate and new device comply with the listed IEC 60601-1 and IEC 60601-1-2 standards (note: predicate listed 2005 version for 60601-1 and new device listed 2014 version for 60601-1-2, but the document states "SAME", implying continued compliance with the relevant versions).
Size / Weight (Comparable, but allows for differences)	340 lb., 154.2 KG	Significantly different: Predicate is 110 lbs. / 50 kG. This is a clear difference, but likely addressed by the "Mobile X-ray system" classification and overall safety/effectiveness assessment.
Exposure Times (Comparable or acceptable range)	.01 - 5.00 sec	Slightly different: Predicate is 0.01 - 3.33 sec. New device has a longer maximum exposure time.
mA Range (Comparable or acceptable range)	10 - 50 mA	Slightly different: Predicate is 12.5-60 mA. New device has a lower minimum and maximum mA.
kW (Comparable or acceptable range)	5.0 kW	Improved: Predicate is 3 kW. New device has higher power.
kVp (Comparable or acceptable range)	40 - 110kVp 41 steps	Slightly different: Predicate is 40 - 120kVp 80 steps. New device has a lower maximum kVp and fewer steps.
CR/DR Compatible	YES (with OPTIONAL computer, panel, and software: Flat Panel: ViZion DR Panel 14 x 17 Wireless, Viztek (K152279), 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 Screen)	Both are "YES". The new device explicitly details the optional digital components, which are themselves apparently FDA-cleared (K152279). This represents an enhancement rather than a fundamental change to the X-ray system itself.
Safety and Effectiveness Verification	"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."	This is the overall conclusion of the substantial equivalence justification. The non-clinical testing results support this.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: This submission does not involve a "test set" in the context of an AI algorithm or a clinical study with patient samples. The testing conducted was non-clinical bench testing, safety agency testing, and software validation. There is no mention of a traditional "test set" size as one would describe for an algorithm performance study.
Data Provenance: Not applicable. The testing described is performance testing of the device hardware and software, not data collected from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a 510(k) submission for an X-ray device, not an AI algorithm requiring expert ground truth for interpretation of medical images. The "ground truth" for this device's performance is its adherence to internal specifications and external safety/performance standards, verified through engineering tests.

4. Adjudication Method for the Test Set

Not applicable. There is no test set requiring adjudication in this context.

5. 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. This submission is for an X-ray device, not an AI-assisted reading tool. Therefore, an MRMC study is not relevant and was not performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is an X-ray device, not a standalone algorithm. While it mentions optional digital imaging components (panel and software), these are themselves FDA-cleared components (Viztek K152279) presumably validated separately. The focus here is on the X-ray generator and mobile system.

7. The Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence claim is multi-faceted:
- Compliance with recognized electrical safety and performance standards: IEC 60601-1, IEC 60601-1-2, and 21 CFR 1020.30/1020.31.
- Bench testing results: Measurements of kVp calibration, mA calibration, timer tests, mAs display, Half Value Layer, reproducibility, linearity, radiation leakage, collimator light illuminance and alignment, and X-ray field coverage.
- Software validation: Ensuring the software functions as intended and meets design specifications.
- Risk analysis: Identifying and mitigating potential hazards.
- Comparison to the predicate device's established performance and safety.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI algorithm trained on a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no training set for an AI algorithm in this context. The "ground truth" for the device's development and testing involved engineering specifications, design inputs, and regulatory standards.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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)

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."

{3}------------------------------------------------

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

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
1. 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.
1. 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.

{4}------------------------------------------------

6. Substantial Equivalence Chart

	K090655 Model PowerMax 1260Portable X-Ray System	UC-5000 Mobile X-Ray
Intended Use:	The Model PowerMax 1260 PortableX-Ray System is intended for GeneralPurpose Portable RadiographicApplications (Not for mammographicuse. Language later required by FDA)	The UC-5000 Mobile X-Ray is intendedfor General Purpose Radiographicexams utilizing film, computedradiography, or direct digital flat panels.Not for mammographic use. (Languageadded 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 Anode130 kVp Target Material TungstenAnode Capacity 45,000 HU StorageFocal Spot 1.2 mm; Target Angle 15°	SAME
CR/DRCompatible	YES	SAME, now available with OPTIONALcomputer, panel, and softwareFlat Panel: ViZion DR Panel14 x 17 Wireless, Viztek (K152279),High Quality Wireless 14" X 17" DigitalPanel, Amorphous Silicon Scintillator150 x 150 micron pixel sizeSoftware: Opal Rad Imaging SoftwareViztek also cleared in K152279.Features:Window / Level; Image Preview;DICOM Print / Store; Fast ImageProcessing; (image displayed within 3seconds);Computer: 20" All-In-OneTabletkiosk PC (TAIO20T) with Touch
	K090655 Model PowerMax 1260Portable X-Ray System	UC-5000 Mobile X-Ray
		Screen
Collimator	Collimare Model CPL-125-UC01-C	SAME
	This device complies with allapplicable performance standardsunder 21 CFR 1020.30 and 1020.31.	This device complies with all applicableperformance standards under 21 CFR1020.30 and 1020.31.
Standards	IEC 60601-1: 2005 ANSI Medicalelectrical equipment - Part 1: Generalrequirements for basic safety andessential performance	SAME
	IEC 60601-1-2: 2014 Medicalelectrical equipment - Part 1-2:General requirements for basic safetyand essential performance - CollateralStandard: Electromagneticdisturbances - Requirements and test	SAME
Photo	Image: Portable X-Ray System	Image: Mobile X-Ray
	K090655 Model PowerMax 1260Portable 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

{5}------------------------------------------------

{6}------------------------------------------------

1. 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.
1. 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.
1. 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.

Regulation Number and Section

§ 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.