The XGEO GU60A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Description

The XGEO GU60A digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, Collimator and etc.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "XGEO GU60A Digital Diagnostic X-ray System." It outlines the device's intended use and compares it to a predicate device, but it does not contain acceptance criteria or a study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Revolution XR/d of General Electric Company) for regulatory purposes. It mentions various tests conducted for safety, EMC, and performance according to established standards (e.g., IEC 60601 series, 21 CFR 1020.30, 21 CFR 1020.31, and FDA guidance for 510(k)s for Solid State X-ray Imaging Devices). It states, "All test results were satisfied," which implies the device passed, but it does not specify what those acceptance criteria were or present the detailed results of those tests.

Therefore, most of the requested information cannot be extracted from this document, specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "All test results were satisfied" for safety, EMC, and performance tests, but does not list specific criteria or performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided. The document mentions "Non-clinical testing and Clinical Testing were conducted," but gives no details about sample size, provenance, or study design.

3. 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 provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.

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: Not explicitly stated. The device is a "Digital Diagnostic X-ray System" for generating images, not an AI-powered diagnostic aid that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is unlikely for this type of device as described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a hardware system for image acquisition, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided, as detailed clinical study results are absent.

8. The sample size for the training set: Not provided. This device is an X-ray imaging system, not an AI model that typically requires a training set in the same context.

9. How the ground truth for the training set was established: Not provided. (See point 8).

Summary of what is present:

Device Name: XGEO GU60A Digital Diagnostic X-ray System (K123106)
Intended Use: Generating radiographic images of human anatomy by a qualified/trained doctor or technician. Not for mammographic applications.
Predicate Device: Revolution XR/d of General Electric Company.
Studies Conducted (mentioned, not detailed): Electrical, mechanical, environmental safety and performance testing according to IEC 60601 series, 21CFR1020.30, 21CFR1020.31; EMC testing according to IEC 60601-1-2(2001); Non-clinical testing and Clinical Testing in accordance with FDA guidance for 510(k)s for Solid State X-ray Imaging Devices.
Conclusion: The device is safe and effective and substantially equivalent to the predicate device, with all test results reported as "satisfied."

Summary

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Image /page/0/Picture/0 description: The image shows the text "SAMSUNG ELECTRONICS Co., Ltd." The text is in a sans-serif font and is black. The text is arranged on a single line and is centered in the image. The letters are evenly spaced and the text is easy to read.

510(k) Premarket Notification - Traditional

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92

1. Date: June 6, 2013
1. Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea

3. Primary Contact Person

A. Name: Charlie Mack
B. Title: President of International Regulatory Consultants
C. Phone Number: 541-376-5063
D. FAX Number: 541-376-5063
E. E-Mail: charliemack@irc-us.com

4. Secondary Contact Person

A. Name: Shim, Kyungam
Title: Regulatory Affairs Manager B.
C. Phone Number: +82-31-200-3356
FAX Number: +82-31-200-0700 D.
E-Mail: kyungam.shim@samsung.com ய்

5. Device

A. Trade Name: XGEO GU60A
Common Name: Digital Diagnostic X-ray System B.
். Regulation: 21 CFR 892.1680
D. Classification Name: System, X-ray, Stationary
E. Product Code: KPR

6. Device Description

The XGEO GU60A digital X-ray imaging system is to be used to take and store image for

JUN 2 0 2013

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SAMSUNG ELECTRONICS Co., Ltd.

Image /page/1/Picture/1 description: The image shows the word "SAMSUNG" in white letters against a black background. The word is written in a bold, sans-serif font. The black background is in the shape of an oval, with the word "SAMSUNG" centered inside. The image is a logo for the Samsung company.

510(k) Premarket Notification - Traditional

diagnosis of patients. It consists of the High voltage generator (HVG), U-arm positioner, Detector, X-ray tube, Collimator and etc.

7. Intended Use

8. Comparison with predicate device :

Samsung Electronics Co., Ltd., believes that the XGEO GU60A is substantially equivalent to the Revolution XR/d of General Electric Company.

Comparison with the predicate device made through the system component items such as detector, generator etc., has been proven to be similar in many ways, but differences in the seven items were found. Specifically, even if the differences of the capacity and size of High Voltage Generator, Ceiling Suspension, Wall stand and Patient table exists, these are considered minor impact on the safety and performance. Also, Collimator, Detector, and Image Process Function in terms of the design and the technology characteristic have differences in the following characteristics:

Configuration : PD and the proposed device have different configurations. PD is a ceiling type and the proposed device is a U-arm type. But it has no effect on safety.
Auto Positioning : The proposed device provides the auto positioning function. But it has no effect on safety.
High Voltage Generator : The specifications of high voltage generators are different. But it has no effect on safety. The proposed device has the lower output rating and wider time range which makes the mAs range of both devices similar.
Blade moving method: Motorized method for adjusting a collimator radiation field is only available. It just concerns on the method for control a radiation field and has not effect on safety.
Number of pixels : Number of pixels is different. A detector with a large number of pixels can cover a wider area of body. It has no effect on safety.
Pixel pitch : Pixel pitch, a measurement that indicates the distance between pixels and determines an image resolution, is different. It affects the image quality but it has

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SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

not effect on safety.

High contrast limiting resolution : High contrast limiting resolution is different due to the difference of the pixel pitch. The resolution is higher as the value of the pixel pitch is lower. It affects the image quality but it has no effect on safety.
DQE : The value of DQE is different. The detector type with CSI phosphor has higher DQE value. It affects the image quality but it has no effect on safety.
MTF : The value of MTF is different. The detector type with CSI phosphor has higher MTF value. It affects the image quality but it has no effect on safety.
Robust FPD : PD and proposed device have "Flat Panel Detector". And detector in proposed device has been passed reliability test (include drop test) so it is named "Robust FPD".
Adaptive Local Contrast Stretching : PD and proposed device have "Contrast enhancement image processing algorithm". And "Algorithm" in proposed device name is "ALCOS"
Remote Access : PD and proposed device have "Remote Access" function for Remote management system
Collision Avoidance System : PD and the proposed device have a function that prevents collisions with foreign objects, but detection sensors are different.
Micro Processor Controlled High Frequency Switching : PD and the proposed device have HVGs that include a microprocessor-based control system. Also, the control system uses a high frequency switching method to provide the required voltage and current outputs.
Full-Auto (Adaptive) mA Calibration : PD and the proposed device have the auto mA calibration function that can compensate for effects like filament aging. "Adaptive mA Calibration" is also used for the same function.

However, these differences do not have an effect on safety and effectiveness compared with the predicate device, Revolution XR/d of General Electric Company.

In summary, the XGEO GU60A does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

In conclusion, the XGEO GU60A is substantially equivalent to Revolution XR/d of General Electric Company.

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SAMSUNG ELECTRONICS Co., Ltd.

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510(k) Premarket Notification - Traditional

9. Safety, EMC and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-2-54, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). And Non-clinical testing and Clinical Testing were conducted in accordance with Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" (issued August 6, 1999). All test results were satisfied.

10. Conclusions :

ﺮ

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Samsung Electronics Co., Ltd. concludes that The XGEO GU60A is safe and effective and substantially equivalent to predicate devices as described herein.

1. Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

June 20, 2013

SAMSUNG ELECTRONICS Co., Ltd. % Mr. Charlie Mack Principle Engineer International Regulatory Consultants (IRC) 77325 JOYCE WAY ECHO OR 97826

Re: K123106

Trade/Device Name: XGEO GU60A Digital Diagnostic X-ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 21, 2013 Received: May 29, 2013

Dear Mr. Mack:

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 andadulteration. 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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Page 2 - Mr. Mack

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Sm.h.7)

for

Janine M. Morris 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): K123106

Device Name: Digital Diagnostic X-ray System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

210(k) - K123106

Page 1 of

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.