Who is the manufacturer of XGEO GF50?

Samsung Electronics Co., Ltd. filed the 510(k) submission for XGEO GF50 (K140326).

What is the FDA product code for XGEO GF50?

KPR. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for XGEO GF50?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like XGEO GF50?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

XGEO GF50

K140326 · Samsung Electronics Co., Ltd. · KPR · May 29, 2014 · Radiology

Device Facts

Record ID	K140326
Device Name	XGEO GF50
Applicant	Samsung Electronics Co., Ltd.
Product Code	KPR · Radiology
Decision Date	May 29, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

The XGEO GF50 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 Story

The XGEO GF50 is a stationary digital diagnostic X-ray system used in clinical settings by trained medical professionals. It captures radiographic images of human anatomy (head, chest, spine, abdomen, joints, extremities). The system transmits X-rays through the patient to a digital detector, which converts the radiation into electrical signals. These signals are amplified, converted to digital data, and processed by the XGEO Station (operation software). The resulting images are saved in DICOM format and transmitted to a PACS server for clinical review. The system includes a high-voltage generator, collimator, patient table, and wall stand. It supports both wired and wireless detector connectivity. By providing high-quality digital images, the device assists clinicians in diagnostic decision-making. It is not intended for mammography.

Clinical Evidence

Clinical evidence consisted of a concurrence study involving qualified radiologists. The study evaluated images produced by the XGEO GF50 against the predicate device. Radiologists concluded that the XGEO GF50 provides images of equivalent diagnostic capability to the predicate device. No specific sensitivity/specificity metrics were reported; the conclusion of substantial equivalence is supported by both clinical evaluation and non-clinical bench testing (MTF/DQE measurements).

Technological Characteristics

Stationary digital X-ray system; a-Si TFT photodiode array detector with CsI scintillator; high-frequency generator (max 52kW); floor-mounted or floor-ceiling configuration; DICOM connectivity (wired/wireless); software-based image processing; electromagnetic brake locking; halogen lamp beam light source; complies with IEC 60601-1, IEC 60601-1-2, and IEC 62220-1.

Indications for Use

Indicated for generating radiographic images of human anatomy for patients requiring diagnostic X-ray imaging. Not indicated for mammographic applications. Intended for use by qualified/trained doctors or technicians.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

XGEO GC80 (K123098)

Related Devices

K140334 — XGEO GC80 · Samsung Electronics Co., Ltd. · May 28, 2014
K150165 — GC85A · Samsung Electronics Co., Ltd. · Apr 2, 2015
K201725 — DigitalDiagnost C50 · Philips Healthcare (Suzhou) Co., Lit. · Jul 10, 2020
K163115 — GC70 · Samsung Electronics Co., Ltd. · Dec 7, 2016
K040995 — SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 · Analogic Corp. · May 25, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the Samsung logo, which is a black oval with the word "SAMSUNG" in white letters inside. There is also some handwritten text above the logo, which appears to say "Page 1". The handwriting is cursive and slightly slanted. 510(k) Premarket Notification - Traditional SAMSUNG ELECTRONICS Co., Ltd. ## MAY 2 9 2014 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: 2014. Feb. 06 - 2. Submitter - Company Name: SAMSUNG ELECTRONICS Co., Ltd. A. - B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea #### Primary Contact Person 3. - Name: Donald D. Fickett A. - Title: Vice President Regulatory & Quality Assurance B. - Phone Number: 978-564-8523 ﻥ - FAX Number: 978-750-6677 D. - E-Mail: dfickett@samsungneurologica.com E. #### Secondary Contact Person 4. - Name: Ha, Aeyoung A. - B. Title: Regulatory Affairs Manager - C. Phone Number: +82-31-200-1537 - FAX Number: +82-31-200-1199 D. - E-Mail: ay.ha@samsung.com E. #### Device 5. - Trade Name: XGEO GF50 A. - B. Common Name: Digital Diagnostic X-ray System - Classification Name: System, X-Ray, Stationary ். - D. Product Code: KPR #### હ. Predicate Device - Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. A. - B. Trade Name: XGEO GC80 - C. 510(k) Number: K123098 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the Samsung logo. The logo is in black and white. The word "SAMSUNG" is written in bold, sans-serif letters. 510(k) Premarket Notification - Traditional D. 510(k) Decision Date: 01/08/2013 ### 7. Device Description This system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device being sent to the XGEO Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images. The XGEO GF50 is intended to be used for capturing digital X-ray images of various parts of the body including the head, chest, spine, abdomen, joints, hands, feet and other organs. #### Intended Use 8. The XGEO GF50 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. ### 9. Summary of Technological characteristic of the proposed device compared with the predicate device The XGEO GF50 does not have significant change in materials, energy source or technological characteristics compared to the predicate device. Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates. | Specification | Predicate Device | Proposed Device | Discussion | |---------------|------------------------------------|-----------------------------------|-------------------| | Device Name | XGEO GC80 | XGEO GF50 | | | Manufacturer | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | | | 510(k) Number | K123098 | N/A | | | Appearances | Image: Predicate Device Appearance | Image: Proposed Device Appearance | Equivalent (1) | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the word "SAMSUNG" in white letters against a black background. The word is in all capital letters and is in a bold, sans-serif font. The background is an oval shape, with the word "SAMSUNG" centered in the middle. The logo is simple and modern. 510(k) Premarket Notification - Traditional | Intended Use | The XGEO GC80 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. | The XGEO GF50 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. | Same | |---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Configuration | Ceiling type | Floor-mounted or Floor-ceiling type | Equivalent (1) | | Manufacturer Contents | XGEO GC80 | XGEO GF50 | Discussion | | |---------------------------|----------------------------------------------|----------------------------------------|--------------------------------------------|-------------------| | (1)High Voltage Generator | | | | | | Type | High Frequency | High Frequency | Same | | | Max. Power | 80kW | 52kW | | | | | Tube Voltage | 40-150kV | 40-150kV | Equivalent | | Output RANGE | Tube Current | 10-1000mA | 10-640mA | (2) | | | Exposure Time | 1msec-2sec | 1msec-10sec | | | | AEC (Automatic Exposure Control) | Yes | Yes | Same | | | APR (Anatomically Programmed Radiography) | Yes | Yes | Same | | (2)Ceiling Suspension | | | | | | Moving Range (mm) | Longitudinal | 1350 ~ 3350 (Varies with room size) | 2100(Floor-mounted) 2500(Floor ceiling) | Equivalent (3) | | | Lateral | 770 - 2770 (Varies with room size) | 220 | | | | Vertical | 1800 | 1330 | | | | Vertical Tube Moving method | Motorized/ Manual | Manual | Equivalent | | | Tube Assembly Rotation | -157 ~ +183 | $\pm$ 135 | Equivalent (4) | | | Brake locking Method | Electromagnetic | Electromagnetic | Same | | | Moving Rail Type | Al Extrusion | Steel plate | Equivalent (5) | | | Image Preview | O | O | | | | Display Type | Color LCD | Color LCD | Same | | | Control Switch Type | Button + Touch Screen | Button + Touch Screen | Same | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the SAMSUNG logo. The logo is in white text on a black oval background. The text is in a bold, sans-serif font. 510(k) Premarket Notification - Traditional | Manufacturer Contents | | | | XGEO GC80 | XGEO GF50 | Discussion | |--------------------------------------|---------|----------------------------------|------------------------------|-------------------------------------------|-------------------------------------------|-------------------| | (3) Wall Stand | | | | | | | | Vertical Movement | | Mechanism | | Motorized/ Manual | Manual | Equivalent | | | | Range(mm) | | 400~1,800 | 420~1770 | Equivalent | | Detector | | Mechanism | | Motorized | NIA | Equivalent (6) | | | Tilting | Range | | -20-+90 | | | | | AEC | | | Conventional | Conventional | Same | | Lines/cm | | 84.6 | 84.6 | Same | | | | Grid | | Grid mechanism | | Stationary | Stationary | Same | | | | Removability | | Removable | Removable | Same | | | | Detector Support Mounting | | Floor | Floor | Same | | | | Patient Support Device | | Patient handgrips, lateral support bar | Patient handgrips, lateral support bar | Same | | (4)Patient Table | | | | | | | | | | Size(mm) | | 2433 X 806 | 2200 X 750(4way) 2200 X 810(6way) | Equivalent | | Table Top | Range | | Lateral | ±140 | +125 | (7) | | | (mm) | | Longitudinal | ±480 | +500 | | | Table height | | Mechanism | | DC Motor, Ball screw | DC Motor (6way) | Equivalent | | | | Range(mm) | | 545 - 900 | 565 ~ 850 | Equivalent | | | | Horizontal range of detector(mm) | | 590 | 590 | Same | | | | AEC | | Conventional | Conventional | Same | | | | Lines/cm | | 84.6 | 84.6 | Same | | Grid | | Grid mechanism | | Stationary | Stationary | Same | | | | Removability | | Removable | Removable | Same | | | | Vertical Sync. | | 0 | 0 | Same | | | | Control Switch Type | | Foot switch | Foot switch | Same | | Maximum Patient Weight(kg) | | 350 (Static, Center load) | 250 (Static, Center load) | Equivalent | | | | (5)Collimator | | | | | | | | Overall Size(mm) | | H212 X W300 X D179 | H185 X W213 X D180 | Equivalent | | | | Beam Limiting Blade Moving Method | | Motorized /Manual | Manual | Equivalent | | | | Manual Operation Method | | Volume | Volume | Same | | | | | | Collimator Rotation | | +45 | 400 | Equivalent | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the SAMSUNG logo. The logo is in black and white. The word "SAMSUNG" is written in white letters on a black oval background. 510(k) Premarket Notification - Traditional | | Manufacturer Contents | XGEO GC80 | XGEO GF50 | Discussion | |--|-----------------------------|--------------|--------------|-------------------| | | | | | (8) | | | Beam Light Source | LED | Halogen Lamp | Equivalent (9) | | | Light Field Indicator Timer | O | O | Same | | | Side Lamp | O | O | Same | | | | Laser Module | Laser Module | Same | | | Field Size / SID Display | Color LCD | Color LCD | Same | | Manufacturer Contents | XGEO GC80 | XGEO GF50 | Discussion | | |----------------------------------------------|--------------------------|--------------------------|--------------------------|------------| | (6) Detector | | | | | | Name | SDX-4336CP | SDX-4343CS | S4335-W | | | | CsI | CsI | Same | | | Detector Type | Indirect | Indirect | Indirect | Same | | Detector Area | 14"X17" (351mmX423mm) | 17"X17" (429mmX429mm) | 14"X17" (345mmX425mm) | Equivalent | | Number of pixels | 2340X2820 | 3000X3000 | 2466X3040 | | | Pixel Pitch(um) | 150 | 143 | 140 | Equivalent | | High Contrast Limiting Resolution (LP/mm) | 3.3 | 3.5 | 3.5 | (10) | | Communication | Wired | Wired / Wireless | Equivalent (11) | | | No. | Description | Explanation | |------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (1) | Configuration | Predicate device is a ceiling type digital x-ray imaging system and the proposed device is a Floor-mounted or Floor ceiling type digital x-ray imaging system. The difference of THU location doesn't affect the fundamental scientific characteristic of x-ray operation. | | (2) | High Voltage Generator | The proposed device has the lower output power and tube current specification than the predicate device. The wider time range of proposed device makes the equivalent mAs range to predicate device. | | (3) | Moving range | Due to the nature of Floor-mounted device, it has less flexibility of moving range than ceiling type device. This is a matter of convenience to use. Therefore proposed device is equivalent to predicate device. | | (4) | Tube Assembly Rotation | Predicate device has wider range of the tube assembly rotation than proposed device. The rotation range of proposed device, ± 135, can operate the most of procedure intended for use in general radiography which makes equivalence of the proposed device to predicate device. | | (5) | Moving Rail Type | The moving rail type of predicate and proposed device is designed suitable for each type of device, ceiling and floor mounted type. As the XGEO GF50 is complied with IEC60601-1, the fundamental mechanical safety is equivalent to the predicate device. | | (6) | Detector Tilt | Proposed device doesn't provide detector tilt function. As detector tilt function is an optional function and not an essential requirement for safety and effectiveness of the system, it doesn't affect to the safety and effectiveness. | | (7) | Table size and moving range | Proposed device has 2 types of the patient tables provides option to physicians for their convenience. The patient tables are complied with IEC60601-1 for basic electrical and mechanical safety. Therefore, it is equivalent to the predicate device. | | (8) | Collimator Rotation | Proposed device has more collimator rotation angle than predicate device which gives more flexibility to the collimator positioning for patient. | | (9) | Beam light source | Predicate device used LED lamp and proposed device uses Halogen lamp for beam light source. Halogen lamp is the one generally used light source before LED lamp was used. It is equivalent to the predicate device. | | (10) | Resolution of detector | Proposed detector has better resolution than predicated. In the specification sheet, to compare with the same size detector (SDX-4336CP), proposed detector shows more number of pixels, short pixel pitch and higher contrast limiting resolution. In non-clinical data, the propose detector shows better curves and measurements of MTF and DQE than predicate device. In clinical data, the radiologists evaluate the image of XGEO GF50 is substantially equivalent to predicate device. | | (11) | Communication | Proposed device supports wireless connection and wired connection by tether, while PD only supports wired connection. To ensure the safety and effectiveness of wireless communication between detector and workstation, the wireless function is tested by EN 301 489-1, EN 301 489-17, 47 CFR Part 15C, 47 CFR Part 15E, wireless specification and performance in testing lab and actual environment and evaluated under the risk management followed by a guidance, Radio frequency Wireless Technology in Medical Devices | : ・ {5}------------------------------------------------ ### 510(k) Premarket Notification - Traditional ### 10. Safety, EMC and Performance Data: Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1(2012), 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2007). Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfied. {6}------------------------------------------------ K140322 Page 7 of 510(k) Premarket Notification - Traditional ### 11. Non-clinical data Non clinical test was conducted for imaging performance of the proposed detector. Both of the predicate device and proposed device are based on a-Si TFT photodiode arrays with a scintillator designed for general radiography. MTF and DQE were tested and measured by IEC 62220-1. MTF curves and measurements from the two detectors were compared and it shows that the propose detector perform better than the predicate in terms of the resolution at all spatial frequencies tested. In DQE, the propose device also has better DQE performance at all spatial frequencies tested because scintillator deposition method is different. Therefore, in non-clinical data review, the XGEO GF50 is substantially equivalent with the predicate device. ### 12. Clinical data According to the CDRH guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices, concurrence study was conducted. The evaluation of the qualified radiologists in the study shows that XGEO GF50 provides images of equivalent diagnostic capability to the predicate device. It demonstrates that XGEO GF50 is substantially equivalent with the predicate device. ### 13. Conclusions 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 GF50 is safe and effective and substantially equivalent to predicate devices as described herein. - 14. Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circular border of the logo. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 29, 2014 SAMSUNG ELECTRONICS Co., Ltd. % Jeongpyo Hong Assistant Manager, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si. Gyeonggi-do. 443-742 REPUBLIC OF KOREA Re: K140326 Trade/Device Name: XGEO GF50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 28, 2014 Received: April 29, 2014 Dear Jeongpyo Hong: 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. {8}------------------------------------------------ Page 2-Jeongpyo Hong 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/ResourcesforYou/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 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, Sm.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 {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo is a black oval with the word "SAMSUNG" written in white, sans-serif letters. The letters are bold and slightly slanted. The logo is simple and modern. 510(k) Premarket Notification - Traditional 510(k) Number (if known): Device Name: XGEO GF50 Indications for Use: The XGEO GF50 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. × Prescription Use (Part 21 CFR 801 Subpart D) ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ AND/OR Over-The-Counter Use_ (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![Imgur](https://i.imgur.com/9999999.png)