K Number

Device Name

XGEO GF50

Manufacturer

SAMSUNG ELECTRONICS CO., LTD.

Date Cleared

2014-05-29

(108 days)

Product Code

KPR

Regulation Number

892.1680

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K123098

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard digital X-ray imaging technology and image processing steps (amplification, digital conversion, DICOM saving). There is no mention of AI, ML, or related concepts like algorithms for image analysis, interpretation, or decision support beyond basic image acquisition and storage. The performance studies focus on image quality metrics (MTF, DQE) and diagnostic equivalence based on radiologist review, not AI/ML performance metrics.

Therapeutic

No
This device is an X-ray imaging system, which is used for diagnostic purposes to generate images of human anatomy. It does not provide any form of therapy or treatment.

Diagnostic

The device is an imaging system that generates radiographic images for a qualified/trained doctor or technician to read. It produces images, but does not provide diagnosis.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components like an X-ray source, detector, and signal processing device, in addition to the operation software.

IVD (In Vitro Diagnostic)

Based on the provided information, the XGEO GF50 Digital X-ray Imaging System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body). The XGEO GF50 is used to generate images of human anatomy in vivo (within the body) by transmitting X-rays through the patient.
The intended use and device description clearly state its purpose is for generating radiographic images of human anatomy. This is a form of medical imaging, not in vitro diagnostics.
There is no mention of analyzing biological samples or performing tests on specimens.

Therefore, the XGEO GF50 falls under the category of medical imaging devices, not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

KPR

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human anatomy, various parts of the body including the head, chest, spine, abdomen, joints, hands, feet and other organs.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified/trained doctor or technician

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123098

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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
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

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

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 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.

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)

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 |

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

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

・

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.

K140322
Page 7 of

510(k) Premarket Notification - Traditional

11. Non-clinical data

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.

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

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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.

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

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510(k) Premarket Notification - Traditional

510(k) Number (if known):

Device Name: XGEO GF50

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

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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)

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